| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
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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