The Smokehouse, LLC. d/b/a La Maree Smokehouse 8/31/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Ave. Jamaica, NY 11433

August 31, 2011

WARNING LETTER NYK-2011-34

VIA UNITED PARCEL SERVICE

Panagiota Soublis, President/ Owner
The Smokehouse, LLC.
d.b.a. La Maree Smokehouse
434 Waverly Avenue
Mamaroneck, New York 10543

Dear Ms. Soublis:

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility located at 434 Waverly Avenue, Mamaroneck, New York between February 23 and March 11, 2011 and between March 29 and April 1, 2011, and collected samples of finished products and environmental swabs. FDA laboratory analyses of your refrigerated ready-to-eat cold smoked salmon and environmental swabs from your facility found the presence of Listeria monocytogenes (L. monocytogenes), a human pathogen. The presence of L. monocytogenes in your refrigerated ready-to-eat cold smoked salmon causes this product to be adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §342(a)(1)] in that the product contains a poisonous or deleterious substance which may render it injurious to health. In addition, FDA investigators observed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 [21 CFR §§ 123 and 110]. These violations and the environmental swabs that found L. monocytogenes in your processing facility cause your ready-to-eat seafood products to be adulterated within the meaning of section 402(a)(4) the Act [21 U.S.C. §342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act, the seafood HACCP regulation, the Current Good Manufacturing Practice regulation for foods and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening, illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.

We acknowledge your decision on March 30, 2011 to recall lot code 066 of refrigerated ready-to-eat Norwegian Cold Smoked Salmon Slices, which the FDA found to be contaminated with L. monocytogenes.

Six environmental swabs collected from your facility on March 29, 2011 tested positive for L. monocytogenes. These swabs were collected from: 1) a cutting board used to cut ready-to-eat cold smoked salmon, which was stored after cleaning on a rack near the northwest corner of the processing area; 2) the floor in front of the two-bay sink on the east wall of the processing area; 3) in the middle of the floor drain in front of the smoke oven; 4) on the right side of the floor drain in front of the smoke oven; 5) the wood cover on the right side of the floor drain closest to the east wall of the processing room; and 6) inside of a black dust pan stored in a broom/mop closet by the front entrance to your facility. L. monocytogenes found in the environment of your facility, including food contact surfaces, increases the risk of your finished product becoming contaminated.

Analysis using Pulsed Field Gel Electrophoresis ("PFGE") showed that L. monocytogenes isolates obtained from the FDA sample of your cold smoked salmon collected on March 8, 2011 (manufactured between March 3-7, 2011) and the FDA environmental swabs collected on March 29, 2011, were indistinguishable by both a primary and secondary enzyme. When a PFGE pattern of an isolate is indistinguishable from the pattern of another isolate from a common source, it is highly likely that two isolates are the same strain of L. monocytogenes. These PFGE results suggest that L. monocytogenes may have been transported throughout your facility and demonstrates that sanitation efforts were inadequate to remove this pathogenic organism during this time period. We acknowledge that your firm voluntarily stopped all production from March 29 through approximately April 8, 2011, in an attempt to clean and sanitize your facility to remove L. monocytogenes, and that your firm hired a food safety/HACCP consultant to supervise this cleaning.

FDA investigators also observed the following significant violations of the seafood HACCP regulation [21 CFR § 123]:

1. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR Part 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plans dated March 3, 2011 for Cold Smoked Tuna and Hot Smoked Bluefish, Mackerel, Mahi Mahi, Tuna Halibut do not list the food safety hazard of scombrotoxin (histamine) formation at the Cooler Storage and Storage of Vacuum Packed finished product critical control points.

2. You must have a HACCP plan that, at minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, the following HACCP plans list monitoring procedures that are not adequate:

• HACCP plan for "Cold Smoked Salmon, Halibut" lists a monitoring procedure at the Dry brining cold smoked salmon critical control point which does not include temperature monitoring to control Clostridium botulinum (C. botulinum) growth.

• HACCP plan for "Cold Smoked Salmon, Halibut" lists a monitoring frequency "(b)(4)" at the Cold Storage of Vacuum Packed, finished product critical control point that is not adequate to control pathogen growth and toxin formation, including C. botulinum toxin formation. For refrigerated finished product storage, FDA recommends continuous monitoring by the device itself, with a visual check of the recorded data at least once per day.

• HACCP plan for "Cold Smoked Tuna" lists a Dry brining critical control point which does not include temperature monitoring to control pathogen growth and toxin formation, including C. botulinum toxin formation.

• HACCP plan for "Cold Smoked Tuna" lists a monitoring frequency (b)(4) at the Cooler Storage critical control point that is not adequate to control histamine (scombrotoxin) formation, and pathogen growth and toxin formation, including C. botulinum toxin formation. For refrigerated finished product storage, FDA recommends continuous monitoring by the device itself, with a visual check of the recorded data at least once per day.

• HACCP plan for "Hot Smoked Blue Fish, Mackerel, Mahi Mahi, Tuna Halibut" lists a monitoring frequency (b)(4) at the Storage of Vacuum Packed finished product critical control point that is not adequate to control scombrotoxin (histamine) formation, and C. botulinum toxin formation. For refrigerated finished product storage, FDA recommends continuous monitoring by the device itself, with a visual check of the recorded data at least once per day.

• HACCP plan for "Hot Smoked Salmon" lists a monitoring procedure that does not list salinity or salt concentration of brine at the Dry curing brine critical control point to control pathogen growth and toxin formation, including C. botulinum toxin formation.

• HACCP plan for "Cold Smoked Salmon, Halibut" lists a monitoring procedure at the Dry brining cold smoked salmon critical control point that does not list temperature monitoring to control pathogen growth and toxin formation, including C. botulinum toxin formation.

• HACCP plan for "Hot Smoked Salmon" lists a monitoring frequency (b)(4) at the Refrigerated storage of vacuum pack finished product critical control point that is not adequate to control C. botulinum toxin formation. For refrigerated finished product storage, FDA recommends continuous monitoring by the device itself, with a visual check of the recorded data at least once per day.

• HACCP plan for "Cold Smoked Salmon, Halibut" lists a monitoring frequency (b)(4) at the Cold Storage of Vacuum Packed, finished product critical control point that is not adequate to control C. botulinum toxin formation. For refrigerated finished product storage, FDA recommends continuous monitoring by the device itself, with a visual check of the recorded data at least once per day.

3. You must take corrective action when a deviation from your critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take corrective action to control Clostridium botulinum growth and toxin donation when your process for hot smoked black cod deviated from your critical limit at the Smoking/Cooking Hot Smoke critical control point. For example, on September 15 and 17, 2010, your record entitled "BRINING REPORT" shows a maximum temperature of (b)(4) for hot batch #091510 and batch #091710 of hot smoked black cod, respectively.

4. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b).

• However, your corrective action plan for Cold Smoked Tuna, and Hot Smoked Bluefish, Mackerel, Mahi Mahi, Tuna, Halibut at the Receiving critical control point to control histamine (scombrotoxin) formation and pathogen growth are not appropriate. Your corrective actions do not correct the cause of the deviation, e.g., discontinue use of supplier or carrier until evidence is obtained that transportation practices have changed.

• However, your corrective action plan for Cold Smoked Tuna, and Hot Smoked Bluefish, Mackerel, Mahi Mahi, Tuna, Halibut at the Cooler Storage, Brining and Smoking critical control points are not appropriate. Your corrective actions do not indicate how you will regain control over the operation and address the problem that caused the critical limit deviation.

• However, your corrective action plan for Cold Smoked Salmon, Halibut, and Hot Smoked Salmon at the Receiving critical control point to control bacterial pathogen growth are not appropriate. Your corrective actions do not correct the cause of the deviation, e.g., discontinue use of supplier or carrier until evidence is obtained that transportation practices have changed.

• However, your corrective action plan for Cold Smoked Salmon, Halibut, and Hot Smoked Salmon at the Dry brining and Smoking critical control points are not appropriate. Your corrective actions do not indicate how you will regain control over the operation and address the problem that caused the critical limit deviation.

5. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR § 110, to comply with 21 CFR § l23.11(b). However, your firm did not monitor the condition and cleanliness of food contact surfaces with sufficient frequency to ensure compliance as evidenced by:

a. On February 23, 2011 and March 29, 2011, the raw salmon that is used for ready-to-eat product is stored on plastic trays covered in a brine solution. Numerous plastic trays (40+) are broken leaving exposed corroded and rusting metal that cannot be cleaned. The salmon and the brine come in direct contact with the exposed metal.

b. On February 24, 2011, the plastic strip air curtain on the entrance to cooler (b)(4) had visible product residue. The FDA investigator observed these curtains to be in direct contact with ready-to-eat cold smoked salmon that were on open and exposed plastic trays that were brought through the curtains into and out of cooler (b)(4) (2/24/11).

c. On February 24, 2011, the FDA investigator observed an employee that was trimming and slicing ready-to-eat cold smoked salmon was slicing ready-to-eat cold smoked salmon and touching the product with his gloved hands, then left the slicing station touched the cooler door for cooler (b)(4) with gloved hands, then touched the plastic air curtain, then touched the racks that the cold smoked salmon are stored on, then touched the plastic air curtain again, then the outside of the cooler door, and then directly handled ready-to-eat cold smoked salmon with his gloved hands without changing his gloves and without washing and sanitizing his hands.

d. On March 29, 2011, After cleaning and prior to production, product residue was observed on the following utensils: knives used to cut fresh ready-to-eat cold smoked salmon; needle nose pliers used to take bones out of ready-to-eat cold smoked salmon; knife sharpener used to sharp the knives used on the ready-to-eat cold smoked salmon.

We acknowledge that at the close of the inspection conducted between February 23 and March 11, 2011, your Director of Operations, Brett H. Portier, provided HACCP plans dated March 3, 2011. However, your firm has not submitted any written response to the FDA Inspectional Observations or evidence that corrective actions have been implemented.
 

In addition, the Food and Drug Administration has determined that your facility is subject to the registration requirement in Section 415 of the Act (21 U.S.C. § 350d) and our implementing regulation at 21 CFR Part 1, Subpart H. The failure to register a facility as required is a prohibited act under Section 301 (dd) of the Act (21 U.S.C. § 331 (dd)). Our records indicate that, to date, your facility has not been registered with FDA.

The owner, operator, or agent in charge of your facility, or an individual authorized by your facility's owner, operator, or agent in charge, should register the facility with FDA immediately. Registration may be accomplished on-line at http://www.access.fda.gov. We strongly encourage the use of electronic registration because it will result in an automatic confirmation of registration and automatic issuance of a registration number.

Alternatively, the owner, operator, or agent in charge of this facility, or an individual authorized by the facility's owner, operator, or agent in charge, may register the facility by mail or fax (e.g., if you do not have reasonable access to the Internet) using FDA's food facility registration form, Form 3537. Form 3537 has been attached to this letter for your convenience. This form may be obtained by calling the FDA Industry Systems Help Desk at 1-800-216-7331 or 301-575-0156, or by writing to the agency at the following address:

U.S. Food and Drug Administration, HFS-681
5600 Fishers Lane
Rockville, MD 20857

When completed, the form may be faxed to (301) 210-0247 or mailed to the address above. FDA will process registrations submitted by mail or fax and provide a facility's registration number using the same method used to submit the registration to FDA.

We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as HACCP and verification records, specific steps you have taken to address sanitation-related problems in your facility (cracked floor tiles, standing water around drains and in processing areas, accumulation of food residues on equipment and utensils after cleaning operations) as these conditions may contribute to further contamination of your facility and food with L. monocytogenes, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Ms. Aveta at 718-662-5576.

Sincerely,
/S/
Ronald M. Pace
District Director
New York District

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Luitpold Pharmaceuticals, Inc. 8/31/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New York District 158-15 Liberty Ave. Jamaica, NY 11433

August 31, 2011

 

WARNING LETTER NYK-2011-33

                                                           

                                                                       

VIA UNITED PARCEL SERVICE

 

 

Mary Jane Helenek

President and CEO

Luitpold Pharmaceuticals, Inc.

One Luitpold Drive

Shirley, New York 11967

 

Dear Ms. Helenek:

 

During our February 9, 2011 to March 15, 2011 inspection of your pharmaceutical manufacturing facility, Luitpold Pharmaceuticals, Inc., located at One Luitpold Drive, Shirley, New York, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic  Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls  used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

 

We have reviewed your firm’s response of April 5, 2011, and note that it lacks sufficient corrective actions.  

 

Specific violations observed during the inspection include, but are not limited, to the following:

 

1.      Your firm does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess [21 C.F.R. § 211.100(a)]. For example:

 

a.       The (b)(4) threshold used by your firm to trigger an investigation, as per your Standard Operating Procedure (SOP) 103.14, “Master Production and Control Records,” is not appropriately defined or scientifically justified. SOP 103.14 requires the initiation of an investigation if (b)(4). This (b)(4) reject limit is uniformly applied to all products you manufacture. Furthermore, the investigation instructions in SOP 103.14 contradict the need for an investigation if the number of vials rejected during inspection exceeds the reject limit. Notably, if the rejection limit is exceeded, (b)(4).

 

In your response, your firm states that you will conduct a thorough review of every product and apply statistical criteria to establish scientifically justifiable reject limits. Your response, however, is inadequate because you do not commit to assess the different types of observed particulate matter or develop appropriate criteria for each type of particulate matter. In addition,  adequate interim controls had not been implemented at the time of your response to improve risk mitigation of this recurring problem during ongoing production.

 

b.      You have not adequately justified the sample sizes used by the QC Microbiology Laboratory to determine sub-visible particulates via (b)(4) method in your small volume parenteral products. Your firm based your lot or batch acceptance/rejection criteria on a (b)(4). According to your SOP 302.11, (b)(4). Your response is inadequate because the inspection plans referenced in the SOP (302.110) and protocol PR-90-195 do not adequately address detection of the atypical variability present in your current manufacturing operation. It is important that each lot is appropriately sampled and tested for particulate matter prior to its release. While your response indicates that adjustments are being made, the SOP is unclear as to what inspection level you are using, and the corresponding (b)(4) and (b)(4) values are incorrect as demonstrated in the following:
 

• Your response states that your future statistical sampling plan is based on using the valid (b)(4) value from (b)(4) at a batch size between (b)(4) and (b)(4) at an (b)(4) sampling plan letter (b)(4). In your response your firm committed that all Particulate Matter testing will be based on (b)(4) inspection with an (b)(4) of (b)(4). However, (b)(4), equates to an (b)(4), which is inconsistent with your commitment of an (b)(4).   For (b)(4), to achieve an (b)(4), you will have to use (b)(4). For (b)(4) to achieve an (b)(4) at (b)(4) with lot sizes of (b)(4) to (b)(4), you will have to use (b)(4) with accept on (b)(4).
• For fill sizes less than 25 ml, you are collecting (b)(4) samples (b)(4), this equates to a lot disposition action on (b)(4) with corresponding (b)(4) and (b)(4) respectively. This is not equivalent to an (b)(4) plan as claimed in your SOP. 
• There is no scientific rationale for selecting (b)(4) for lot release and (b)(4) for retain sample inspections. According to (b)(4) 

c.       SOP 103.05, “(b)(4),” does not provide adequate instructions to assure correction of significant deviations and CAPA implementation. For example, the root cause analysis provisions do not include extending the investigation to other lots, examining trends for a product or deviation category, or evaluating adequacy of limits (e.g., for incoming raw materials, drug product).  

 

This contributed to your failure to resolve the particulate contamination, which is a persistent and serious issue at your firm for many years. For example in 2009, there were (b)(4) lots with observed particulate matter and since 2010, there have been over (b)(4) lots observed with particulate matter. Your failure to follow written procedures, complete investigations, adequately scrutinize different defect types, determine root cause, and implement appropriate corrective action resulted in exposure of patients to adulterated drugs.

 

Your response provides an outline of a new investigation process and the commitment to reexamine prior investigations. Your response is deficient since you have not included or implemented a revised procedure as part of your response.

 

2.      Your firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed, or extend those investigations to other batches of drug product that may have been associated with the specific failure or discrepancy [21 C.F.R. § 211.192]. 

 

For example, your firm failed to conduct a thorough investigation or extend such investigations to other unexpired lots when a 12 month reserve sample of Potassium Phosphate (lot 0048) revealed translucent visible particles. Without adequate justification, your firm’s Deviation Report (DR) 2457 stated the root cause was glass delamination resulting from a manufacturing variation in the 5ml (b)(4) glass (lot 1001055). Your firm failed to extend the investigation to other unexpired lots of Potassium Phosphate made with the same (b)(4) glass. Between February 2^nd and 10^th, 2011, two additional lots of Potassium Phosphate (lots 0625 and 9065) were found with translucent visible particles.

  

In your response, your firm describes the enhancement of the investigation process with quality oversight and management controls, reexamination of previously conducted investigations, and the implementation of a comprehensive investigation process. However, your response is inadequate because you fail to determine the root causes of the other particulates identified in your products. In the absence of a root cause determination and the lack of implemented corrective action, other

 

products could contain particulate matter contaminants. An analysis of the potential impact of the particulates observed in your marketed lots should be included in your response to this letter.

 

Lack of thorough particulate and product failure investigations are repeat violations from October 2010, October 2009, and November 2008 inspections.

           

3.      Your firm failed to withhold containers from use until each lot of components, drug product containers, and closures had been sampled, tested, or exampled, as appropriate, and released by the quality control unit [21 C.F.R. § 211.84(a)]. Your firm also has not established the  reliability of the supplier’s analyses through appropriate validation of the supplier’s test results at appropriate intervals for the drug product containers [21 C.F.R. § 211.84(d)(3)]. For example:

1. Your firm failed to withhold from use, until after quality control testing and release, numerous lots of glass vials. These lots were conditionally released in accordance with your SOP 804.13, (b)(4) which allows for this inappropriate practice. In addition, these glass vial lots were provided by non-certified supplier locations.
2. You have not established the reliability of the supplier’s analyses for containers at appropriate intervals. Your practice also violates your SOP 303.01, “Inspection and Release of Packaging Components,” for the (b)(4) glass vials, which states that you will conduct USP and Functional & Dimensional testing (b)(4).    

Your response is inadequate because you did not address the corrections to your supplier computer software that will identify the manufacturing location for each lot of glass received to ensure that appropriate testing is conducted. Your response also fails to address a global review of all components to ensure that all components, drug product containers, and closures are appropriately tested to ensure the reliability of the supplier’s analyses.

 

4.      Your firm has failed to routinely calibrate, inspect, or check automatic equipment in accordance to an adequately written program designed to assure proper performance [21 C.F.R. § 211.68(a)]. 
 

For example, the SOP, SOP 601.23, Validation of the (b)(4) for the annual qualification of the (b)(4) does not include a requirement to evaluate contamination particle sizes discovered in your products from past investigations or recovered from an external forensic laboratory. The (b)(4) are qualified to identify particle size ranges (b)(4) and (b)(4). However, past investigations have identified particles less than (b)(4) and greater than (b)(4). In some cases, the (b)(4)have only been qualified to evaluate (b)(4) particle size. For example, (b)(4) has been qualified only with (b)(4) sized particles in the most recent validation dated 10/21/10.

 

You response fails to provide assurance that the annual qualification of the (b)(4) demonstrate they can effectively remove vials with particulate matter, and do so across sufficiently representative vial sizes and types. We also note that your response, which states that an (b)(4) rejection rate of test vials on the (b)(4) is acceptable performance, contradicts the qualification acceptance criteria in your SOP 601.23, “(b)(4),” that requires (b)(4) to reject (b)(4) or more test vials with particulates.

 

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility.  You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations.  It is your responsibility to assure compliance with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter.  Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and injunction.  Other federal agencies may take this Warning Letter into account when considering the award of contracts.  Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected.  FDA may re-inspect to verify corrective actions have been completed.

 

If, as a result of receiving this Warning Letter or in general, you are considering making a decision that will result in a decreased number of finished drug products or active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER's Drug Shortages Program immediately, as you begin your internal discussions, at drugshortages@fda.hhs.gov in order to ensure that your action(s) does not adversely affect the public health.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date  by which you will have completed the correction. Additionally, your response should state if you no longer manufacture the drug product(s) manufactured at this facility, and provide the date(s) and reason(s) you ceased production. 

 

Your reply should be sent to the following address: U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. Attention: Lillian C. Aveta, Compliance Officer.

 

 

Sincerely,

/S/ 

Ronald M. Pace

District Director

New York District

 

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EPI, LLC. 8/31/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Chicago District 550 West Jackson Blvd., 15th Floor Chicago, Illinois 60661 Telephone: 312-353-5863

 

August 31, 2011

 

WARNING LETTER

 

CHI-09-11

 

 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

 

Mr. Louis Tenore, Jr.

Owner

EPI, LLC

100 East Street

Poplar Grove, Illinois 61065-9787

 

Dear Mr. Tenore:

 

The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 100 East Street in Poplar Grove, Illinois, on November 2, 8, 18, and 29, 2010.  Our investigators documented serious deviations from the current Good Manufacturing Practice (cGMP) requirements for manufacturing, packaging, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110).  The inspection revealed that conditions in your facility have caused the food products manufactured and stored there to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342 (a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health.  You may find the Act, guidance, and additional information regarding the regulations through links in FDA's home page at www.fda.gov.

 

Our inspection of your facility revealed the following cGMP deviations:

1. You do not use water which is safe and of adequate sanitary quality in food and food-contact surfaces, to comply with 21 CFR 110.37(a) , which specifies that running water at a suitable temperature, and under pressure as needed, shall be provided in all areas where required for the processing of food, for the cleaning of equipment, utensils, and food-packaging materials, or for employee sanitary facilities. During the inspection, our investigators documented the following:

• Un-tested well water is used to manufacture finished food products.
• Hot water was not available during the inspection.

2. You do not have plumbing adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant to comply with 21 CFR 110.37(b)(2). Specifically, on 11/2/201, a sump pump was observed pumping water through a black corrugated sump hose to an open sewer pipe. Sewage was observed spraying out of the hose along its entire length and spraying throughout the production room.

3. Your facility’s plumbing constitutes a source of contamination to food, water supplies, equipment, and utensils and therefore does not comply with 21 CFR 110.37(b)(3). Specifically, four faucets were observed mounted on poles with a hose attached that were not protected with any backflow prevention device in production area of the facility where Ready-To-Eat (RTE) food products are manufactured. The faucets for supplying water to each of the kettles are installed below the flood level rim.

4. Your facility’s plumbing is not adequately installed and maintained to properly convey sewage and liquid disposable waste from the plant to comply with 21 CFR 110.37(b)(2) The production hose used to transfer drainage and waste materials from the open drainage pit in the center of the room to the open floor drain in the cherry processing room is connected directly to the sewer line. During the inspection, the hose was leaking and spraying waste water and other materials across the cherry processing room floor.

5. Your facility’s plumbing is not adequately installed and maintained to provide adequate floor drainage to comply with 21 CFR 110.37(b)(4). Specifically, on 11/2/2010 three separate sump pits located in the production room were not draining and pooling sewage was observed in and around each of the sump pits. The concrete floor around all the drains throughout the facility is damaged, which allows sewage to pond on the floors in all production areas.

6. You do not provide employees with readily accessible and adequate toilet facilities to comply with 21 CFR 110.37(d). Specifically, the toilet facilities are inadequate and are only usable by employees when management turns the water on to that location.   Moreover, the toilet facilities were not maintained in a sanitary condition to comply with 21 CFR 110.37(d)(1). The bathroom sink was soiled with iron deposit, mold and grime.

7. You do not keep toilet facilities in good repair to comply with 21 CFR 110.37(d)(2). There is only one functional toilet located in the facility. The one functional toilet does not have a functional flush lever.

8. You have toilet doors open into areas where food is exposed to airborne contamination, and there are no alternative means taken to prevent such contamination, which is a violation of 21 CFR 110.37(d)(4). Specifically, there are no outer doors for the bathroom facility and the two individual toilet room doors were both open and exposed to the coconut processing area.

9. You do not provide hand washing and hand sanitizing facilities at each location in the plant where needed to comply with 21 CFR 110.37(e)(1). Our investigators observed the following:

• There were no hand washing or sanitizing facilities in the cherry production or cherry picking rooms where maraschino cherries are manufactured.
• No operational hand washing facilities were available in the coconut processing room where ready to eat food products are handled by employees.

10. Your hand-washing facilities do not comply with 21 CFR 110.37(e), which requires hand-washing facilities to be convenient and be furnished with running water at a suitable temperature. Specifically, our investigators noted the following:

• There were no hand-washing sinks located in any production areas, including the cherry processing room, picking room, and coconut processing room.
• There was no running water available at the hand washing facility or at the shipping room sink for employees to have access to wash their hands.
• The hose located in the coconut processing room, which was observed being used by one employee to rinse off his hands after packaging (b)(4) was only capable of delivering cold water.

11. You do not have sanitary towel service or suitable hand drying devices to comply with 21 CFR 110.37(e)(3). Specifically, it was observed that there are no hand towels or hand drying devices located in the hand washing facility or at any location throughout the entire facility.

12. You do not have devices and fixtures such as water control valves designed and constructed to protect against recontamination of clean, sanitized hands to comply withy 21 CFR 110.37(e)(4). Specifically, investigators observed that the fixtures on the hand sink located in the employee bathroom contained iron-like deposits and mold-like residues. 

13. All reasonable precautions shall be taken to ensure that production procedures do not contribute to contamination from any source to comply with 21 CFR 110.80. However the following was observed: 

• Pumps and piping used for pumping products and re-circulating product are deteriorated with duct-type taping around the openings and seams.
• Hoses used to add water for soaking cherries are stored in direct contact with the insanitary concrete flooring. The hoses are in direct contact with in-process product are not sanitized prior to production.

14. Your facility does not have posted, readily understandable signs directing employees to wash and sanitize hands as appropriate to comply with 21 CFR 110.37(e)(5). Specifically, there are no signs posted throughout the entire facility directing employees to wash their hands as appropriate. 

15. Your employees do not wash and sanitize hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any time their hands may have become soiled or contaminated to comply with 21 CFR 100.10(b)(3). Our investigators observed the following:

• The firm's manager and an additional employee were observed manufacturing and packaging (b)(4). No hand-washing occurred before, during, or after the processes by the manager and only after the process by the other employee. Prior to this process both employees were observed performing other functions such as cleaning equipment, handling raw materials, and eating.

16. Your employees do not wear hair nets where appropriate to comply with 21 CFR 110.10(b)(6). Specifically, employees were not wearing hair nets or any hair restraint while manufacturing Maraschino Cherries.

17. You are required to provide your employees with suitable outer garments are not worn that protect against contamination of food, food contact surfaces, and food packaging materials to comply with 21 CFR 110.10(b)(1). Investigators observed that employees were not wearing outer garments during the manufacturing of (b)(4) to protect against the contamination of food, food-contact surfaces, or food packaging materials. Employees were observed performing multiple functions such as cleaning equipment, handling raw waste and raw materials prior to food handling of RTE foods.

18. Responsibility for compliance with 21 CFR 110 was not assigned to competent supervisory personnel as required by 21 CFR 110.10(d).

• Your facility managers have had no training or previous experience regarding food sanitation and during the inspection, demonstrated lack of knowledge through non-use and lack of availability of hand sanitizers or hand-washing facilities, improper storage and use of soiled non-food contact equipment during processing, improper storage of waste, improper storage or raw materials, improper use of cleaning detergents, and improper cleaning and sanitizing of processing areas and equipment.

19. You do not take proper precautions to protect food, food-contact surfaces, and food-packaging materials from contamination with microorganisms, filth, and extraneous material to comply with 21 CFRR 110.20(b)(2). This cannot be taken because of deficiencies in plant construction. Specifically, our investigators observed the following:

• Cracks and crevices in the floors, walls, and ceilings, as well as the external structure of the building.
• There were holes in windows located in the cherry processing room and a missing window in the picking room.

20. Your plant is not constructed in such a manner as to prevent drip and condensate from contaminating food, food-contact surfaces, food-packaging materials and your plant must be constructed in such a manner as to allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair to comply with 21 CFR 110.20(b)(4) . During the inspection of your facility, investigators observed the following:

• Rusted and dripping plumbing in the cherry processing area, picking area, and coconut processing area. On 11/02/2010, a plastic tarp was observed over cherry production kettle (b)(4). The tarp, covering three 8x8 ceiling shields over the (b)(4) cherry holding tanks, contained holes.
• Investigators observed buckets on the floor in the picking room that were being used to catch condensate and pouring water coming from overhead steam piping in the production area.
• The floors throughout the facility (including the storage room, cherry processing room, picking room, and coconut processing room) were porous and contained numerous cracks and crevices with deteriorated concrete exposing the aggregate and loose gravel.
• Walls and ceilings contained chipping and peeling paint in the storage, cherry processing, picking room, coconut processing room, hand-washing facility and there was mold-like residue on the walls located in the picking room and coconut processing room.

21. You do not provide adequate screening or other protection against pests to comply with 21 CFR 110.20(b)(7). Specifically, our investigators observed the following:

• On 11/2/10, approximately twelve rodent-like excreta pellets (REP) were observed behind pallets of coconut located along the east-facing wall of the coconut processing room.
• On 11/02/2010, a gap of more than 1 inch was observed under the south facing delivery door and service door located in the storage room.
• On 11/02/2010, approximately 20 - 30 box elder bugs were observed behind mouse trap #8 located near the service door on the south wall of the storage room.
• Missing window panes for windows located in the cherry processing room and picking room contain no window coverings or screen to protect against pests.
• There was a live plant growing through the window located on the south side of the east wall located in the storage room that hung down at least 7 feet.

22. You do not properly store equipment, remove litter and waste, and cut weeds or grass that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures to comply with 21 CFR 110.20(a)(1). Specifically, our investigators observed overgrown grass and weeds up to 18 inches in height around the entire perimeter of the processing facility. The overgrown weeds and grass will not allow for routine inspection of the facility and constitute a harborage area for pests.

23. You do not provide safety-type light bulbs and lighting fixtures suspended over exposed food to comply with 21 CFR 110.20(b)(5). Specifically, the lighting fixtures suspended directly over all the picking tables used to sort out cherries with pits, do not contain safety-type light bulbs or any other protective covering to eliminate glass fragments from direct contact with food. The overall lighting is inadequate throughout the facility.

24. You do not have adequate ventilation to minimize odors and vapors in areas where they may contaminate food to comply with 21 CFR 110.20(b)(6). Specifically, there is no ventilation in the toilet facilities to prevent odors and vapors from migrating out into food processing areas.

25. You do not clean and sanitize food-contact surfaces in wet-processing before use and after any interruption during which they may have been contaminated, to preclude contamination with microorganisms to comply with 21 CFR 110.35(d)(2). Specifically, there are no sanitizers located on the premises to adequately sanitize utensils and equipment before or after processing. Employees currently uses [(b)(4)] detergent to clean the cherry soaking tanks, sugar kettles, and picking tables, but equipment is not further sanitized prior to use.

26. You do not maintain buildings fixtures, and other physical facilities of the plant in a sanitary condition or keep them in repair sufficient to prevent food from becoming adulterated within the meaning of the act as required by 21 CFR 110.35(a). Food and food packaging materials left uncovered were being stored directly beneath leaking ceilings and ceilings with chipped and peeling paint and mold. Peeling paint, rust, and mold were observed on the walls and ceilings throughout the production area.

27. You do not conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food and food-contact surfaces to comply with 21 CFR 110.35(a). Specifically, the chemical used in the cleaning process (b)(4) container was not identified, so that the proper storage conditions or use of this product on food-contact surfaces could be adequately followed by employees. 

28. Your facility does not have corrosion-resistant food contact surfaces to comply with 21 CFR 110.40(a). Specifically, on 11/02/2010, corrosion was observed within the tanks and kettles located in the cherry processing room used to manufacture Maraschino Cherries.

29.  Non-food-contact equipment in manufacturing and food handling areas is not constructed, so that it can be kept in a clean condition to comply with 21 CFR 110.40(c). Specifically, numerous pieces of equipment such as the measuring scale, picking tables, and concrete base of cherry soaking tanks are deteriorated and do not have smooth surfaces so as to be easily cleanable.

30. You do not store finished food under conditions that would protect against physical, chemical, and microbial contamination to comply with 21 CFR 110.93. Our investigators observed the following:

• Finished Maraschino Cherries being stored in your firm’s toilet facilities.
• Barrels of old and decaying cherry product were stored uncovered next to finished product.

You are required to investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including, but not limited to, seizure and injunction.

 

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective action you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

 

Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, at the address above. If you have any questions regarding any issues in this letter, please contact Ms. Sexton at 312-596-4225 or rosemary.sexton@fda.hhs.gov.

 

 

Sincerely,

/S/

Scott J. MacIntire

District Director

 

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Willharvdoit Corporation 8/30/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN  55401 Telephone: (612) 334-4100 FAX: (612) 334-4142

August 30, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11 - 50

William P. Harvey
President/Owner
Willharvdoit Corporation
4706 West State Street
Milwaukee, Wisconsin  53208

Dear Mr. Harvey:

We inspected your seafood processing facility, located at 4706 West State Street, Milwaukee, Wisconsin, on May 10 to June 10, 2011.  We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods (21 CFR 123 and 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4).  Accordingly, your Tuna Salad and fish patty sandwiches are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.

We acknowledge receipt of your response to the Form FDA-483 dated June 23, 2011, which included a description of your corrections, as well as a revised HACCP plan and supporting documentation. Review of the response revealed continued concerns that are addressed below.

Your most significant violations were as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for frozen ready-to-eat fish patty sandwiches to control the hazards of pathogen growth and undeclared allergens.

2. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1).  A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.”  However, your firm’s revised HACCP plan submitted with your June 23, 2011, response entitled “Fully Cooked Ready-to-eat Fish Sandwiches,” which is intended to cover your tuna salad sandwiches does not list the food safety hazards of Clostridium botulinum growth and toxin formation, and histamine.  The plan lists various pathogens as hazards, however, the most likely hazards associated with your tuna salad sandwiches are Clostridium botulinum toxin formation and histamine formation because you are receiving (i.e., from a previous processor) and further processing the tuna salad as a ready-to-eat refrigerated product.   

With regard to the food safety hazard of Clostridium botulinum growth and toxin formation, we note that you receive your tuna salad in (b)(4) pound containers and your firm packages the final sandwich products in a heat-sealed wedge container that is oxygen impermeable. Both of these types of packaging do not provide a sufficient exchange of oxygen to allow aerobic spoilage organisms to grow and spoil the product before the toxin is produced when the products are exposed to moderately abusive temperatures.  Consequently, these products need a secondary barrier, in addition to refrigeration, to control toxin formation. FDA has several recommended strategies for secondary barriers, and one such strategy is control of the pH to a value of 5.0 or below. FDA collected samples of your raw material tuna and finished product sandwiches. The results of the pH determinations showed that the incoming raw material and the finished sandwich products all exhibited pH value slightly higher than 5.0 (i.e.,  between 5.2 and 5.88). We suggest that because your tuna is already somewhat reduced in pH that your firm adopt a strategy to control the pH to 5.0 or below. This may be done by conducting lot-by-lot testing of a representative sample of each lot of tuna salad received. This method allows you to set your temperature critical limits at 40°F. Another method of control is to affix time and temperature integrators (TTIs) to each finished sandwich package. This method requires temperature critical limits to be set at 38°F.  These control strategies, along with others, are further explained in Chapter 13 of the Fish and Fisheries Products Hazards and Controls Guidance, 4th edition.

3. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3).  A critical limit is defined in 21 CFR 123.3(c) as “the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard.”  However, your firm’s revised HACCP plan for tuna salad sandwiches submitted with your June 23, 2011, response fails to list a critical limit necessary to control pathogen growth and toxin formation (i.e., associated with the various pathogens listed in the plan) at the “Receiving Refrigerated Ingredients” critical control point. Because you are receiving product that is transported less than four hours in refrigerated trucks, FDA recommends that in addition to monitoring product temperatures you list a critical limit associated with transport time to ensure that transport times are less than four hours. The time element should include the time at which the product was first removed from a controlled temperature environment before shipment (i.e., at the shipper’s facility). Additionally, FDA currently recommends that processors monitor a minimum of 12 containers (or all containers for lots smaller than 12).
 
In addition, because infrared thermometers are referenced in your plan and are a thermometer that is primarily used on surfaces, your plan should indicate that you will be taking “surface” temperatures of the containers at receipt.

4. You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4).  However, your firm’s revised HACCP plan for tuna salad sandwiches submitted with your June 23, 2011, response lists monitoring procedures at the “Finished Product Labeling” critical control point that are not adequate to control the identified hazard of “Presence of allergens in finished product.”  Specifically, your plan does not reference a comparison of the finished product labels with the product formula or ingredients declaration to ensure accuracy of the labeling.

5. Because you chose to include a corrective action plan in your HACCP plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plans listed in your HACCP plan for your tuna salad sandwiches are not appropriate to control pathogen growth at the: 

o “Receiving Refrigerated Ingredients” critical control point, in that the listed corrective actions of (b)(4) cannot be implemented by your firm. The (b)(4) can not be determined based on (b)(4), which is listed as your monitoring procedure at (b)(4). (b)(4) can only be implemented with (b)(4). Your plan also fails to list correcting the cause of the deviation, such as “discontinue of supplier” or some other means to address proper correction to the cause of deviation.

o “Ingredient Cooler Storage Temperature” and “Finished Product Cooler Storage” critical control points, in that the corrective actions fail to list remedial actions to prevent further deterioration of the product (e.g., by adding ice or moving product to another cooler) and fail to address correcting the cause of the deviation such as repairing the coolers. 

We also acknowledge that in your response you state that you have corrected or are in the process of correcting the sanitation deficiencies. We are requesting that you provide a timeline for these corrections, particularly replacement of the processing belt. Corrections to the other sanitation deficiencies will be confirmed during our next inspection.

This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.

Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence.  If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.

Please send your reply to the Food and Drug Administration, Attention:
Tyra S. Wisecup, Compliance Officer, at the address on this letterhead.  If you have questions regarding the issues in this letter, please contact Ms. Wisecup at (612) 758-7114.

Sincerely,

/s/

Gerald J. Berg
Director
Minneapolis District

 

 

 

 

-

Forsman Farms, Inc. 8/30/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN 55401 Telephone: (612) 334-4100 FAX: (612) 334-4142

August 30, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11- 51

Gary Forsman
CEO/President
Forsman Farms, Inc.
P.O. Box 699
Cokato, Minnesota 55321

Dear Mr. Forsman:

The Food and Drug Administration (FDA) inspected your shell egg production facility located at 6339 Mowery Avenue SW, Howard Lake, Minnesota, on April 12-15, 2011. During the inspection FDA found that your facility had serious violations of the Prevention of Salmonella enteritidis in Shell Eggs During Production, Storage, and Transportation regulation (the shell egg regulation), Title 21, Code of Federal Regulations, Part 118 (21 CFR 118). Failure to comply with the provisions of 21, CFR 118 causes your shell eggs to be in violation of section 361(a) of the Public Health Service Act (the PHS Act), 42 U.S.C. § 264(a). In addition, these violations render your shell eggs adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have"been rendered injurious to health. You may find the Act, the PHS Act, and the shell egg regulation through links on FDA's home page at www.fda.gov.

Your significant violations were as follows:

1. Although your rodent monitoring indicated unacceptable rodent activity within your poultry houses, you failed to use appropriate methods to achieve satisfactory rodent control, as required under 21 CFR 118.4(c)(1). Specifically, between the weeks of September 29, 2010, and March 23, 2011, your firm recorded that the sum of trapped rodents found in all of your egg laying houses during the course of each of those weeks was in excess of (b)(4), resulting in a rodent index that exceeded (b)(4) for each of these weeks. However, you failed to use appropriate methods to achieve satisfactory rodent control. Your written response dated April 26, 2011, stated that you have changed your threshold level at which you will take corrective action to (b)(4) from (b)(4). You also stated that you have changed the rodent control section of your written Salmonella enteritidis (SE) prevention plan to state that additional corrective action will only be taken after rodent monitoring finds the rodent index is exceeded for (b)(4) consecutive weeks. FDA finds that your proposed correction to this violation is not adequate. The changes you have made to your SE plan are not appropriate methods to achieve satisfactory rodent control.

2. You failed to procure pullets that are SE monitored or to raise pullets under SE monitored conditions, as required under 21 CFR 118.4(a). SE monitoring includes testing the pullet environment for SE when pullets are 14 to 16 weeks of age, as required under 21 CFR 118.4(a)(2)(i). Specifically, our inspector learned from your test records that hens from Barn (b)(4) flock #105004, include pullets from Montevideo, MN, houses 205, 206, 207, which were not tested for SE between 14 to 16 weeks of age. The pullet house testing was completed on July 2, 2010, when the pullets were approximately 12 weeks of age. We acknowledge that your SE plan currently specifies that pullet houses be tested within the correct age range.

3. You failed to hold eggs at or below 45 degrees Fahrenheit ambient temperature beginning 36 hours after time of lay, as required under 21 CFR 118.4(e). Specifically, your Loader Cooler that is used to hold shell eggs intended for the table market was not maintained to provide a temperature at or below 45 degrees Fahrenheit. Temperatures in the Loader Cooler were documented above 45 degrees Fahrenheit at several different points in time, including throughout the time period from April 13 - 10, 2011. Documentation also showed eggs being held in the Loader Cooler during that time period that were more than 36 hours past the time of lay. Your written response dated April 26, 2011, stated that you had ordered a new cooling unit. FDA will verify this correction during the next inspection.

4. You failed to fully implement your written SE prevention plan, as required under 21 CFR 118.4. Specifically:

• You did not take the corrective actions described in your plan when your plan parameters for rodent activity levels were exceeded. The rodent control section of your written SE prevention plan states that corrective action must be taken and recorded when weekly rodent monitoring results in a rodent index exceeding (b)(4). However, on at least five occasions between the weeks of September 29, 2010, and March 23, 2011, you took no corrective action even though your weekly rodent monitoring resulted in a rodent index exceeding (b)(4).

• You did not take the corrective actions described in your plan when your plan parameters for temperature control were exceeded. The refrigeration policy section of your written SE prevention plan states that any time the temperature in your cooler falls above or below the 40-45 degree Fahrenheit range specified in your plan, a corrective action must be taken in order to fix the problem. However, your records indicate that the temperature in your Loader Cooler repeatedly exceeded 45 degrees Fahrenheit in December 2010, March 2011, and April 2011. It was not until April 13, 2011, that your records indicate the planned corrective action of purchasing a backup cooling system.

5. You failed to maintain records documenting compliance with the refrigeration requirements of the shell egg regulation, as required under 21 CFR 118.10(a)(3)(iv). Specifically, you did not maintain documentation of the temperature conditions of your Loader Cooler between July 9, 2010, and September 21, 2010. Your written response dated April 26, 2011, acknowledges that no records were created and implemented for monitoring the cooler temperature until September 2010 and that the cooler temperatures have been recorded daily since September 22, 2010.

This letter is not intended to be an all-inclusive list of violations at your facility. You are responsible for ensuring that your shell egg production facility operates in compliance with all applicable statutes and regulations, including the Act, the PHS Act, and the shell egg regulation. You also have a responsibility to use procedures to prevent further violations of these statutes and regulations.

You should respond in writing within 15 working days from your receipt of this letter. Your response should outline the specific things you have done or plan to do to correct these violations and prevent their recurrence. You should include in your response documentation and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections within 15 working days, you should explain the reason for your delay and the time within which the remaining corrections will be completed.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures under 21 CFR §118.12(a).

Please send your reply to the Food and Drug Administration, Attention: Tyra S. Wisecup, Compliance Officer, at the address in the letterhead. If you have questions regarding any issues in this letter, please contact Ms. Wisecup at the number listed in this letter's header.

Sincerely,
/S/
Gerald J. Berg
Director
Minneapolis District
 

-

South Texas Innovative Medicine 8/29/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampshire Ave. Silver Spring, MD 20993-0002

AUG 29 2011

WARNING LETTER

VIA UNITED PARCEL SERVICE

Donald A. Rhodes, D.P.M.
dba South Texas Innovative Medicine
60018 South Staples Street
Corpus Christi, TX 78413

Dear Dr. Rhodes:

 

This Warning Letter is to inform you of objectionable conditions observed during the Food and Drug Administration (FDA) inspection of South Texas Innovative Medicine from April 5, 2011, to April 8, 2011, by investigators from the FDA Dallas District Office. The purpose of this inspection was to determine whether your activities as sponsor/investigator of the (b)(4) device clinical study complied with applicable federal regulations.

(b)(4) is a device as that term is defined in section 201 (h) (21 U.S.C. 321 (h)) of the Federal Food, Drug, and Cosmetic Act (the Act), in that it is intended for use in the diagnosis, cure, treatment, or prevention of disease or to affect the structure or function of the body. This letter also requests prompt corrective action to address the violations cited and discussed in your May 2, 2011, written response to the noted violations.

The inspection was conducted under a program designed to ensure that data and information contained in requests for Investigational Device Exemptions (IDE), Premarket Approval (PMA)  Applications, and Premarket Notification (510(k)) submissions are scientifically valid and accurate. Another objective of the program is to ensure that human subjects are protected from undue hazard or risk during the course of scientific investigations.

From the information collected at the inspection, we could not determine whether your device is a Significant Risk or Non-Significant Risk (NSR) device. Even if the (b)(4) is NSR, you are still in violation of the Act and its implementing regulations as outlined below.

Our review of the inspection report prepared by the district office revealed serious violations of Title 21, Code of Federal Regulations (21 CFR) Part 812-Investigational Device Exemptions, Part 50-Protection of Human Subjects, and Section 520(g) (21 U.S.C. 360j(g)) of the Act. At the close of the inspection, the FDA investigator presented an inspectional observations Form FDA 483 for your review and discussed the observations listed on the form with you. The deviations noted on the Form FDA 483, your written response, and our subsequent review of the inspection report, are discussed below:

1. Failure to obtain Institutional Review Board approval of the investigation [21 CFR 812.2(b)(1)(ii)]

Sponsors are responsible for ensuring that Institutional Review Board (IRB) approval is obtained before beginning an investigation or part of an investigation. For an investigation of a device other than a significant risk device, the sponsor must obtain IRB approval of the investigation after presenting the reviewing IRB with a brief explanation of why the device is not a significant risk device, and maintain such approval.

You failed to obtain IRB review and approval of the (b)(4) device investigation. Without IRB approval, there is no assurance that subject risks are minimized and reasonable in relation to anticipated benefits, adequate provision for data monitoring is in place, and additional safeguards for children are addressed.

2. Failure to ensure that each investigator obtains from each subject, informed consent under part 50 [21 CFR 812.2(b)(1)(iii)]

For an investigation of a device other than a significant risk device, the sponsor must ensure that each investigator participating in the investigation obtains from each subject under the investigator's care, informed consent under part 50 and documents it, unless documentation is waived by an IRB under 21 CFR 56.109(c). In seeking informed consent, basic elements, and additional elements when appropriate, must be provided to each subject (21 CFR 50.25). Informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative at the time of consent (21 CFR 50.27).

As a sponsor/investigator, you failed to ensure that proper informed consent, including assent where appropriate, was obtained. Although subjects or subjects' legally authorized representatives signed Prototype Treatment Release forms, the forms were not reviewed and approved by an IRB. Moreover, the forms lack all the basic elements required by 21 CFR 50.25. As such, informed consent was not documented in accordance with 21 CFR 50.27. Without valid informed consent, there is no way to assure that the rights and welfare of research subjects are adequately protected.

We acknowledge your May 2, 2011, response in which you claim that you do not have to comply with sections 514 and 515 of the Act and are exempt from IDE requirements because the (b)(4) is a custom device. However, your response is inadequate because the (b)(4) is not a custom device.
 

As defined in 21 CFR 812.3(b), which mirrors section 520(b) of the Act (21 U.S.C. 360U)(b)), a custom device is a device that:

(1) necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;

(2) is not generally available to, or generally used by other physicians or dentists;

(3) is not generally available in finished form for purchase or for dispensing upon prescription;

(4) is not offered for commercial distribution through labeling or advertising; and

(5) is intended for use by an individual patient named in the order of a physician or dentist, and is to be made intended to meet the special needs of the physician or dentist in the course of professional practice.

To be considered a custom device, a device must meet all of the above criteria; failure to meet anyone of the above definition's criteria means that a device is not a custom device and must comply with applicable premarket approval and IDE requirements.

Your device fails to (b)(4) criteria. For example, your clinical study of the device on (b)(4) subjects means that it does not "necessarily deviate" from applicable premarket approval requirements. See 48 FR 56778, 56796, Dec. 23, 1983 ("a device [must] be sufficiently unique that clinical trial investigations would be impracticable"). Failure to meet this criterion is also suggested by statements on your website, www.paindefeat.com. explaining that you are preparing a submission to FDA for the (b)(4), and statements on your Prototype Treatment Release forms indicating that subjects agree to return the prototype in exchange for an FDA-approved device upon FDA approval. Because it is practicable to conduct a clinical investigation for the (b)(4), it cannot be a custom device.

In addition, in your May 2, 2011, response, you claim that the (b)(4) is not part of a clinical study and that it is not part of any IDE study approved by any IRB. Section 520(g) of the Act exempts investigational devices in clinical studies from various requirements of the Act, including clearance and approval, provided they meet certain requirements. If it is not part of a clinical study, then the (b)(4) is in violation of PMA approval and 510(k) clearance requirements, among others.

 

The violations described above are not intended to be an all inclusive list of problems that may exist with your clinical study. It is your responsibility as a study sponsor/investigator to ensure compliance with the Act and all applicable regulations.

We request that you stop enrolling new study subjects and inform currently enrolled subjects that they should stop using the device until IRB approval and valid informed consent can be obtained.

Within 15 working days of receiving this letter, please provide documentation of the actions that you have taken or will take to correct these violations and to prevent the recurrence of similar violations in current or future studies for which you are the study sponsor/investigator. Any submitted corrective action plan must include projected completion dates for each action to be accomplished as well as a plan for monitoring the effectiveness of your corrective actions. Failure to respond to this letter and take appropriate corrective action could result in the FDA taking regulatory action without further notice to you.

In addition, please send us the following information relating to the (b)(4): its indications for use, the risks involved with using this device, the possible benefits from using the device, and your study protocol.

Your response should reference "CTS # EC110028/E001" and be sent to:

Attention: Anne T. Hawthorn
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Division of Bioresearch Monitoring
10903 New Hampshire Avenue
Building 66, Room 3504
Silver Spring, Maryland 20993-0002.

A copy of this letter has been sent to FDA's Dallas District Office, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. Please send a copy of your response to that office.

The Division of Bioresearch Monitoring has developed introductory training modules in FDA-regulated device clinical research practices, which are available on the FDA website. The modules are for persons involved in FDA-regulated device clinical research activities. These modules are located at the following website address: http://www.fda.gov/Training/CDRHLearn/ucm162015.htm.
 

If you have any questions, please contact Anne T. Hawthorn, (301) 796-6561 or Anne.Hawthorn@fda.hhs.gov.

Sincerely yours,

/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

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Dakota Pure Water, Inc. 8/29/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Minneapolis District Office Central Region 250 Marquette Avenue, Suite 600 Minneapolis, MN  55401 Telephone: (612) 334-4100 FAX: (612) 334-4142

August 29, 2011

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 11 – 49

Kevin J. Wittmayer
Owner
Dakota Pure Water, Inc.
3431 Fourth Avenue SW, Suite B
Fargo, North Dakota  58103-2227

Dear Mr. Wittmayer:

On June 3 and 6, 2011, a Food and Drug Administration (FDA) investigator conducted an inspection of your bottled water manufacturing facility located at 3431 Fourth Avenue SW, Suite B, Fargo, North Dakota. Our findings revealed violations of the Processing and Bottling of Bottled Drinking Water Regulations, Title 21, Code of Federal Regulations (21 CFR), Part 129, and the Current Good Manufacturing Practice regulation for foods, 21 CFR Part 110. 

By virtue of these violations, the product processed at your facility is adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. You may find the Act and FDA’s regulations through links on FDA’s Internet home page at www.fda.gov.

The FDA investigator provided you with a form FDA 483, which presents the investigator’s observations. The following violations were observed, some of which were also noted during FDA’s previous inspection of your facility in April 2009:

1. You have failed to take and analyze product samples for bacteriological purposes at least once a week from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day’s production, as required by 21 CFR 129.80(g)(1). This requirement applies to all finished bottled water products, regardless of source. Specifically, since the conclusion of your last FDA inspection on April 30, 2009, you have not submitted weekly samples for bacteriological analysis.  Records show that you submitted water samples to (b)(4) only on the following dates, although water is typically bottled each week of the year:

• 2009:  May 7, July 23, and October 15
• 2010:  March 9, March 17, April 6, June 2, July 27, September 29, November 9, November 18, and December 27
• 2011:  January 3, February 7, March 7, March 16, March 30, and April 19

2. You have failed to take and analyze at least annually for chemical, physical, and radiological purposes a representative sample from a batch or segment of a continuous production run for each type of bottled drinking water produced during a day’s production, as required by 21 CFR 129.80(g)(2). This requirement applies to all finished bottled water products, regardless of source. Specifically, you have not submitted any samples for chemical, physical, or radiological analysis since your last FDA inspection on April 30, 2009. Failure to conduct annual chemical, physical, and radiological testing of bottled water products was also noted during the previous inspection.

3. You have failed to store and hold toxic chemicals in a manner that protects against contamination of food, food-contact substances, or food-packaging materials, as required by 21 CFR 110.35(b)(2). Specifically, the FDA investigator observed open containers of various household chemicals stored in the production area near the water bottling area and water coolers.

4. You have failed to provide running water at a suitable temperature in your hand-washing facilities, as required by 21 CFR 110.37(e).  Specifically, your employees informed the FDA inspector that the sink used for hand washing lacked hot water, and this was verified by the FDA investigator.  Water was cool to the touch and remained cool to the touch after the faucet ran for four minutes.

This letter may not list all the violations at your facility. You are responsible for ensuring your firm operates in compliance with the Act and FDA’s implementing regulations, including the bottled water regulations (21 CFR Part 129), and the Current Good Manufacturing Practices regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action, including seizure and/or injunction, without further notice.

In addition to the violations discussed above, we have the following comment. You have failed to sample and inspect containers and closures to ascertain that they are free from contamination, as specified in 21 CFR 129.80(f).

We received your letter dated June 28, 2011, which responded to the FDA 483. Although your response indicates that corrections have been made, the response is inadequate because it does not include any documentation or records to show that you have made the necessary corrections.

Please respond in writing within 15 working days of your receipt of this letter outlining the specific steps you have taken to bring your firm into compliance with the law. Your response should include each step taken to correct the violations and prevent their recurrence.  If you cannot complete all corrections within 15 working days, we expect you to explain the reason for the delay and state when any remaining violations will be corrected.

Please send your reply to the Food and Drug Administration, Attention: Timothy G. Philips, Compliance Officer, at the address on this letterhead.  If you have questions regarding the issues in this letter, please contact Mr. Philips at (612) 758-7133.

Sincerely,

/s/

Gerald J. Berg
Director
Minneapolis District

 

TGP/ccl

 

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CHG Hospital Beds, Inc. 8/29/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	10903 New Hampsbire Avenue Silver Spring, MD 20993

AUG 29 2011

WARNING LETTER

VIA UNITED PARCEL SERVICE

Mr. Don Roussy
Chairman and CEO
CHG Hospital Beds, Inc.
153 Towerline Place
London, Ontario
Canada N6E 213

Dear Mr. Roussy:

During an inspection of your firm located in London, Ontario, on April 26, 2011, through April 29, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Spirit hospital bed. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321 (h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or it is intended to affect the structure or function of the body.

Our inspection revealed that your firm's hospital beds are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant violations include, but are not limited to, the following:

1. Failure to submit an MDR within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

For example, your firm received information through its Service Report SR0134A, dated October 5, 2010, of a patient that fell over the side rails of your firm's bed and sustained a broken hip. When the nurse reentered the room, the nurse call alarm was not sounding at the bed or the nurse call station. It was indicated that the nurse call outlet was damaged and had loose connections. Your firm reported this event in its complaint file as CA-007, dated October 8, 2010. Your firm's MDR evaluation determined, "Serious injury not caused/contributed by product," and no report was submitted to FDA.
 

A broken hip meets the definition of a serious injury in that it represents a permanent impairment of a body structure and would necessitate medical intervention to preclude permanent impairment of a body structure.

Your response dated May 11, 2011, appears to be adequate because you submitted an MDR to FDA regarding the event.

2. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR Part 803.17.

a. For example, your firm's MDR procedure does not contain a standardized process or instructions for determining when an event meets the criteria for a MDR. Specifically:

• There are no definitions of what your firm considers to be a reportable event under 21 CFR Part 803.17. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions, based on Part 803.3, of: "become aware"; "caused or contributed"; "malfunction"; "serious injury"; as well as definitions of "reasonably known," based on Part 803.50(b), and "reasonably suggests," based on Part 803.20(c)(1).

• The definition of a (b)(4) Product Complaint in section 6.3 of your firm's MDR procedure excludes events that do not meet this definition, but that still may meet the criteria for reportability under Part 803. It does not address situations in which the device may have caused or contributed to a death, or has malfunctioned and a recurrence of the malfunction would be likely to cause or contribute to a death or serious injury.

• Section 8.1 of your firm's MDR procedure does not include the phrase, "caused or contributed to" when discussing how an event will be evaluated for reportability.

• There are no instructions how to conduct an investigation to determine the cause of an event.

• It is not clear to whom your firm's MOR procedure is referring in section 8.13, when it references "manufacturer/developer." CHG is considered to be the manufacturer of the Spirit Hospital Beds for MDR requirements.

• There are no instructions how to submit reports for events that occur outside the U.S. If an event involves a device that is the same or similar to a device with marketing approval in the U. S., then your firm must also evaluate these events for reportability and submit MDRs as required.

b. Your firm's MDR procedure does not describe its documentation and record keeping process. For example:
 

• There are no instructions for documenting information that was evaluated for reportability determinations or for establishing and maintaining MDR files.

• There is no description how your firm will ensure access to information that facilitates timely follow-up and inspection by FDA.

c. Your firm's MDR procedure fails to provide instructions for the timely submission of complete medical device reports. For example:

• Section 8.6 is misleading. It does not include instructions to submit an MDR within 30 days of becoming aware of information that reasonably suggests that a device your firm markets may have caused or contributed to a reportable event, despite any lack of follow-up information received. If additional information is obtained at a later date that was required or could not be provided when the initial report was submitted, then your firm is required to submit a supplemental report within one month of the day it receives this information.

• An address indicating where to submit MDR reports is not included. The correct address to submit MDRs is: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.

• There are no instructions regarding when your firm must submit 30-day, 5-day, and supplemental or follow-up reports.

• The procedure does not describe the types of information to be included in the FDA Form 3500A.

• There are no instructions requiring your firm to submit all information reasonably known regarding a reportable event.

d. Your firm's MDR procedure does not contain a standardized process for determining when an event meets the criteria for a MDR. For example there are no instructions on how your firm will evaluate information about an event to make timely MDR reportability determinations.

e. Your firm's MDR procedure does not describe its documentation and record keeping process. For example:

• There are no instructions for documenting information that was evaluated for reportability determinations or for establishing and maintaining MDR files.

• There is no description of how your firm will ensure access to information that facilitates timely follow-up and inspection by FDA.

Please note that your firm's MDR procedure contains reporting requirements for other regulatory or competent authorities. To ensure that your firm meets its regulatory obligations for 21 CFR Part 803, we recommend that it develops a MDR procedure as a separate document or, if necessary, as a clearly defined section of a larger document.

We reviewed your firm's response dated May 11, 2011, and the revised document 230-012, (b)(4)" Complaints: and determined that it is not adequate. It addresses when to submit 30-day, 5-day, and supplemental reports, but does not address the other deficiencies listed above.

If your firm wishes to submit MDR reports via electronic submission staff can follow the directions stated at the following URL: http://www.fda.gov/MedicaIDevices/deviceregulationandguidance/guidancedocuments/ucm094529.htm#Where

If you wish to discuss MDR reportability criteria or to schedule further communications, you may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov.

A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate.

U.S. federal agencies may be advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.

Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be cornpleted within fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Please provide a translation of documentation not in English to facilitate our review.

Your response should be sent to: Field Operations Branch/DRMO/OC/CDRH. Refer to CMS case #204934 when replying. If you have any questions about the content of this letter please contact: Valerie A. Flournoy at 301-796-5770 or 301-847-8137 (fax).

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's quality assurance systems.

You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.

Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health

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