AD and AD International, Ltd. 10/31/11

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

 

VIA Electronic Mail

 

OCT 31, 2011

 

To:       info@bestcigarettesshop.com

 

 

 

WARNING LETTER

 

The Center for Tobacco Products of the Food and Drug Administration (FDA) recently reviewed the website, http://www.bestcigarettesshop.com, and determined that your cigarette products listed are offered for sale to U.S. customers. Under section 201(rr) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321(rr)), as amended by the Family Smoking Prevention and Tobacco Control Act, these products are tobacco products because they are made or derived from tobacco and intended for human consumption. Certain tobacco products, including cigarettes, are subject to FDA jurisdiction under section 901(b) of the FD&C Act (21 U.S.C. § 387a(b)).

 

FDA has determined that several of your products are adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)) because you promote them as modified risk tobacco products without an FDA order in effect that permits such promotion. Additionally, FDA has determined that your Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Rich Aroma Apple, Rich Aroma Rum & Cherry, and Sobranie Slims Mints cigarettes are adulterated under section 902(5) of FD&C Act (21 U.S.C. § 387b(5)) or misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)). You can find the FD&C Act through links on FDA’s homepage at http://www.fda.gov.  

 

You describe products that you offer for sale on your website as being “mild” by referring to them as such in product advertising. Specifically, our review of the website revealed that you offer for sale Chesterfield cigarettes with promotional material that reads, “The birthplace of these mild cigarettes is St. Louis, Missouri…” and “‘Chesterfield People: They like a mild smoke, but they don’t like filters’, says the slogan of this brand of cigarettes.”

 

In addition, your website contains the following statements for Epique, Karelia, and Kent cigarettes that you offer for sale on your website:

• Promotional material for Epique cigarettes claiming, “The producer cares a lot about cigarettes are being done only from natural components, without including any chemical elements.”
• Promotional material for Karelia cigarettes claiming, “This brand is clear of using chemical additives, but made of only natural components.”
• Promotional material for Kent cigarettes claiming, “It was a great boom, as Kent cigarettes were the first cigarettes, which had a filter to drastically reduce tar and nicotine,” and, “In 1954 Kent cigarettes got a new filter and a new slogan: ‘Kent takes out more nicotine and tars than any other leading cigarette – the difference in protection is priceless,’ since that time these cigarettes are popular all over the world.” (Emphasis in original).

A tobacco product with a label, labeling, or advertising that uses the descriptors “light,” “mild,” or “low,” or similar descriptors is a “modified risk tobacco product” under section 911(b)(2)(A)(ii) of the FD&C Act (21 U.S.C. § 387k(b)(2)). A tobacco product is also considered a “modified risk tobacco product” under section 911(b)(2)(A)(i) of the FD&C Act (21 U.S.C. § 387k(b)(2)) if its label, labeling, or advertising explicitly or implicitly represents such product as containing a reduced level of a substance, presenting a reduced exposure to a substance, or being less harmful than one or more other commercially marketed tobacco products. Under section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)), no person may introduce or deliver for introduction into interstate commerce any modified risk tobacco product without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)). A product that is in violation of section 911(a) of the FD&C Act (21 U.S.C. § 387k(a)) is adulterated under section 902(8) of the FD&C Act (21 U.S.C. § 387b(8)). Because your website uses the descriptor “mild” for the above-listed products and includes claims that the above-listed products contain a reduced level of a substance, present a reduced exposure to a substance, do not contain or are free of a substance, or are less harmful than other commercially marketed tobacco products, the products are modified risk tobacco products. Because these products are offered for sale to U.S. customers without an FDA order in effect under section 911(g) of the FD&C Act (21 U.S.C. § 387k(g)), these products are adulterated under 902(8) of the FD&C Act (21 U.S.C. § 387b(8)).

 

Additionally, our review of the website revealed that you offer for sale the following cigarettes: Kiss Fresh Apple Superslims, Kiss Strawberry Superslims, Rich Aroma Apple, Rich Aroma Rum & Cherry, and Sobranie Mints 100’s, which are purported to contain an artificial or natural flavor that is a characterizing flavor of the products. Section 907(a)(1)(A) of the FD&C Act (21 U.S.C. § 387g(a)(1)(A)) provides:

 

[A] cigarette or any of its component parts (including the tobacco, filter, or paper) shall not contain, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke.

 

As of September 22, 2009, cigarettes marketed and sold in the United States in violation of this provision are adulterated under section 902(5) of the FD&C Act (21 U.S.C. § 387b(5)). Thus, your flavored cigarettes are adulterated.

 

If, however, these cigarettes do not contain a characterizing flavor, they are misbranded under section 903(a)(1) of the FD&C Act (21 U.S.C. § 387c(a)(1)) as their labeling is false and misleading because it makes the representation that the products contain apple, strawberry, rum and cherry, and mint as characterizing flavors of the tobacco products.

 

You should immediately correct the violations stated above and take any necessary actions to bring your tobacco products into compliance with the FD&C Act. The violations discussed in this letter do not necessarily constitute an exhaustive list, and it is your responsibility to ensure that your tobacco products on this website, or any other websites you own, operate, and/or control, comply with the applicable provisions of the FD&C Act. Failure to ensure full compliance with the FD&C Act may result in FDA initiating further action without notice, including, but not limited to, civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Please note that adulterated and misbranded tobacco products offered for importation into the United States are subject to detention and refusal of admission.

 

Please submit a written response to this letter within 15 working days from the date of receipt describing your corrective actions, including the dates on which you discontinued the violative promotion, advertising, sale, and/or distribution of these tobacco products. 

 

Please direct your response to the following address:

 

PAL-WL Response, Office of Compliance and Enforcement
FDA Center for Tobacco Products
9200 Corporate Boulevard
c/o Document Control Center
Rockville, Maryland 20850. 

 

If you have any questions about the content of this letter, please contact Ele Ibarra-Pratt at (301) 796-9235 or via email at Elenita.IbarraPratt@fda.hhs.gov.   

 

 

Sincerely,
 

/S/

Ann Simoneau, J.D.

Director

Office of Compliance and Enforcement

Center for Tobacco Products

 

 

VIA UPS and Electronic Mail

 

cc: 

AD and AD International Ltd., c/o Dynadot Privacy

P.O. Box 701

San Mateo, CA 94401  

privacy@dynadot.com

 

Wrapers Kitchen 10/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Southwest Region Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3551

October 28, 2011

Ref: DEN-12-03 WL

WARNING LETTER

VIA UPS Overnight Mail

Mr. John Q. Zhao, Owner/President
Wrapers Kitchen
4120 Brighton Boulevard, Suite B-35
Denver, Colorado 80216-3746

Dear Mr. Zhao:

We inspected your seafood processing facility, located at 4120 Brighton Boulevard, Suite B-35, Denver, Colorado, on July 22,28-29, 2011. We found that you have violations of the seafood Hazard Analysis and Critical Control Points (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 & 110]. In accordance with 21 CFR §123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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). Accordingly, your Creamy Cheese Rangoon is adulterated, in that it has 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 in FDA's home page at www.fda.gov.

Your 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 process 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 reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for Creamy Cheese Rangoon to control the food safety hazards of pathogen growth and toxin formation from the growth of Clostridium botulinum as well as major food allergens at the labeling step.
 

We may take further action if you do not promptly correct these violations. For instance, we may take further 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 your HACCP plan, temperature records 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, the seafood HACCP regulation [21 CFR Part 123] and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.

Sincerely,

/S/
La Tonya M. Mitchell
Denver District Director
 

Hayai Zushi 10/28/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Southwest Region Denver District Office Bldg. 20-Denver Federal Center P.O. Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3551

October 28, 2011

Ref: DEN-12-02 WL

WARNING LETTER

VIA UPS Overnight Mail

Ms. Peggy I. Whiting, President
Hayai Zushi
307 West 600 South
Salt Lake City, Utah 84101

Dear Ms. Whiting:

We inspected your seafood processing facility, located at 307 West 600 South, Salt Lake City, Utah, on July 11-13, 15, 2011. We found that you have violations of the seafood Hazard Analysis and Critical Control Points (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 & 110]. In accordance with 21 CFR §123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of 21 CFR 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). Accordingly, your ready-to-eat seafood spring rolls and ready-to-eat squid salads 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 in FDA's home page at www.fda.gov.

Your 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 process 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 reasonable likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for ready-to-eat seafood spring rolls to control the food safety hazard of pathogen growth and toxin formation from the growth of Clostridium botulinum as well as major food allergens at the labeling step.

2. You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for safety of water, prevention of cross-contamination from insanitary objects, maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration; proper labeling, storage and use of toxic chemicals; and control of employee health conditions required for the processing of RTE seafood spring rolls and/or sanitation corrections for any of the above areas of sanitation. Specifically, you do not have any sanitation monitoring records for your ready-to-eat seafood products that include spring rolls and squid salads.

3. You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor three of the eight steps of sanitation with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR 110. For example:

Prevention of cross-contamination from insanitary objects:

• A wooden handled knife was used during production of seafood spring rolls. One employee would wipe the blade of the knife after use with a sanitized towel but the knife handle was never wiped during the production of the seafood spring rolls.

• An employee put on gloves to prepare seafood spring rolls but then proceeded to collect materials from the walk-in cooler and the prep table cooler touching non-food contact surfaces such as that cooler handles, boxes, and containers. The employee then proceeded to prepare the ready-to-eat seafood spring rolls without changing the gloves.

Proper labeling and storage of chemicals:

• A bottle of bleach was being stored above recently cleaned processing equipment.

Protection of food, food packaging material, and food contact surfaces from adulteration:

• Cutting boards used during the production of seafood products are scored, creating a hard to clean surface.

• An employee would scrub the cutting boards with soap and waster and then wipe the soapy water off with a sanitized towel. The sanitizer instructions indicate that equipment should be washed, rinsed and then sanitized.

We may take further action if you do not promptly correct these violations. For instance, we may take further 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 plans and sanitation monitoring records 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, the seafood HACCP regulation [21 CFR Part 123] and the Current Good Manufacturing Practice regulation [21 CFR Part 110]. 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: Carolyn A. Pinney, Compliance Officer, at the above letterhead address. If you have any questions regarding any issue in the letter, please contact Carolyn A. Pinney at (303) 236-3024.

Sincerely,

/S/
La Tonya M. Mitchell
Denver District Director
 

Joe L. Pimentel Dairy 10/27/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District Pacific Region 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 FAX: 510-337-6701

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Our Reference: 3009054762

WARNING LETTER

October 27, 2011

Mr. Jose Joe L. Pimentel, Co-Owner
Mrs. Maria Z. Pimentel, Co-Owner
Joe L. Pimentel Dairy
21102 South Lammers Road
Tracy, California 95304

Dear Mr. & Mrs. Pimentel:

On September 2, 9, and 12, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 20246 South Lammers Road, Tracy, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov. 

We found that you offered for sale an animal for slaughter as food that was adulterated.  Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b.  Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about May 26, 2011, you sold a dairy cow identified with back tag (b)(4), for slaughter as food. On or about May 28, 2011, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 0.41 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640).The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

We also found that you adulterated the new animal drug sulfadimethoxine (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 

Our investigation found that you administered sulfadimethoxine (b)(4) to one of your dairy cows identified with back tag (b)(4) without following the dosage as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur.  Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

Our investigation also revealed that on or about May 26, 2011, you provided to (b)(4), a signed Bill of Sale or Consignment that states that the cows with tag (b)(4) and (b)(4) did not have an illegal level of drug residues. On or about May 26, 2011, you delivered a cow identified with tag (b)(4), which contained a violative sulfadimethoxine residue, to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. § 331(h). You should take appropriate actions to ensure that this violation does not recur.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence.  If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed.  Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Darlene Almogela, Director, Compliance Branch, U.S. Food and Drug Administration, San Francisco District, at 1431 Harbor Bay Parkway, Alameda, California 94502. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 1114 or via e-mail at Karen.Robles@fda.hhs.gov.

Sincerely,

/s/

Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration

 

 

 

 

 

 

 

 

SterilMed, Inc. 10/26/11

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

OCT 26 2011

 

WARNING LETTER

 

VIA UNITED PARCEL SERVICE

 

Brian Sullivan

Chairman & CEO

SterilMed, Inc.

11400 73^rd Ave North, #100

Maple Grove, MN 55369

 

Dear Mr. Sullivan:

 

The United States Food and Drug Administration (FDA) determined that your firm manufactures SterilMed Model 11161M, Modified FemoStop Gold, through your firm’s communication dated July 6, 2011, in response to our It Has Come to Our Attention Letter dated May 26, 2011.  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 is intended to affect the structure or function of the body.

 

We have determined that the SterilMed Model 11161M, Modified FemoStop Gold, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).  For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)]  The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

 

Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. 

 

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.

 

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #228956 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter at 301-796-5587 or 301-847-8139.

 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance. 

 

 

Sincerely yours,

/S/                                            

Steven D. Silverman

Director

Office of Compliance

Center for Devices and

Radiological Health

 

Silveira Ranches 10/26/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	San Francisco District Pacific Region 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 FAX: 510-337-6701

UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED

Our Reference: 3008813145

WARNING LETTER

October 26, 2011

Lorraine F. Silveira, Co-Owner
Anthony F. Silveira, Co-Owner
Silveira Ranches
9501 Redwood Highway
Novato, California 94945

Dear Mrs. & Mr. Silveira:

On August 9, 11, and 17, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 9501 Redwood Highway, Novato, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov. 

Our investigation found that you adulterated the new animal drugs sulfadimethoxine (b)(4), penicillin G procaine (b)(4), florfenicol (b)(4), cephapirin sodium (b)(4), and neomycin-penicillin G procaine (b)(4) Mastitis Tubes containing Neomycin, (b)(4), and Penicillin G Procaine, (b)(4)). Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See Title 21, Code of Federal Regulations, Section 530.3(a), 21 C.F.R. 530.3(a). We have enclosed a copy for your reference.

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 

Our investigation found that you administered sulfadimethoxine (b)(4) to one of your lactating dairy cows identified with ear tag (b)(4) without following the dosage as stated in the approved labeling. Your use of sulfadimethoxine in this manner is an extralabel use. The extralabel use of sulfadimethoxine in lactating dairy cattle is prohibited in accordance with 21 C.F.R. 530.41(a)(9).

Our investigation also found that you administered penicillin G procaine (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the dosage as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).

We found that you administered florfenicol (b)(4) to several of your replacement calves more frequently than prescribed by your veterinarian. Your extralabel use of florfenicol was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).

Also, you administered cephapirin sodium (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the directions for consecutive treatments as stated in the approved labeling. Your extralabel use of cephapirin sodium was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). 

In addition, you administered (b)(4) Mastitis Tubes (containing Neomycin (b)(4), and Penicillin G Procaine (b)(4)) to one of your dairy cows identified with ear tag (b)(4) without following your veterinarian’s directions for consecutive treatments. Your extralabel use of (b)(4) Mastitis Tubes was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a).

Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov. 

Sincerely,

/s/

Barbara J. Cassens
District Director
San Francisco District
U. S. Food and Drug Administration

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

Laser Eye Care of California, LLC 10/26/11

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

OCT 26 2011

 

 WARNING LETTER

VIA UNITED PARCEL SERVICE

Thomas S. Tooma, M.D.
Owner
Laser Eye Care of California, LLC
16255 Ventura Boulevard
Suite 100
Encino, California 91436-2300

Dear Dr. Tooma:

During an inspection of your firm located in Encino, California, on June 8, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device user facility and is subject to the statutory reporting requirements of the Medical Device Reporting (MDR) regulation, found at Title 21, Code of Federal Regulations (CFR) Part 803.

The ophthalmic laser used at your facility to perform Laser-Assisted In Situ Keratomileusis (LASIK) procedures is a medical device 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 the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease, or is intended to affect the structure or function of the body.

Our inspection revealed that your facility's devices 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. Significant violations include, but are not limited to, the following:

Failure to have an adequate MDR procedure describing an internal system that provides for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; a standardized review process or procedure for determining when an event meets the criteria for reporting; and timely transmission of complete medical device reports to the manufacturers and FDA, as required by 21 CFR 803.17(a). For example:

1. There are no definitions of what your facility will consider 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 additional definitions based on Part 803.3 for the following terms: become aware; caused or contributed; MDR reportable event; as well as definitions for the term reasonably known, found in Part 803.30(b), and the term reasonably suggests, found in Part 803.20(c)(1).

2. The procedure includes a (b)(4) for medical complications associated with LASIK surgeries and includes an (b)(4). This information should only be used as a reference and not as the sole means to make MDR determinations. The information included in the reference limits decision making for reportability. For example, serious injuries should not be limited by means of (b)(4). Per 21 CFR Part 803.3, a death or serious injury that was or may have been attributed to a medical device, or when a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of failure, malfunction, improper or inadequate design, manufacture, labeling or user error, is reportable to FDA.

3. The procedure requires the surgeon or clinical director to (b)(4) and the (b)(4) for determination of a reportable event. However, the procedure fails to provide instructions for completing and submitting the FDA Form 3500A to the device manufacturer or FDA, as required by 21 CFR Part 803.32.

4. The procedure does not include the address for submission of MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.

Your firm should take prompt action to correct the violation addressed in this letter. Failure to promptly correct the violation may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm's planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.

If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm's response should be comprehensive and address all violations included in this Warning Letter.

Your firm's response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, MDR Policy Branch, White Oak Building 66, 10903 New Hampshire Avenue, Room 3208, Silver Spring, MD 20993. Refer to the Unique Identification Number #221455 when replying. If you have any questions about the contents of this letter or wish to discuss MDR reportability criteria or schedule further communications, please contact: MDR Policy Branch at (301) 796-6670 or by email at MDRPolicy@fda.hhs.gov.

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

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm's facility. It is your firm's responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.

Sincerely yours,

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

B & F Fish Market Llc 10/26/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New Orleans District 404 BNA Drive Building 200 – Suite 500 Nashville, TN 37217 Telephone: (615) 366-7801       FAX:   (615) 366-7802

October 26, 2011

WARNING LETTER NO. 2012-NOL-02

UNITED PARCEL SERVICE

Delivery Signature Requested

Bobby J. Bassett, Co-Owner

Roy G. Forsha, Co-Owner

B & F Fish Market, LLC

4042 Highway 412 East

Parsons, Tennessee 38363-3613

Dear Messers. Bassett and Forsha:

On June 21 and 23, 2011, a U.S. Food and Drug Administration (FDA) investigator inspected your seafood processing facility, B & F Fish Market, LLC, located at 4042 Highway 412 East, Parsons, Tennessee. We found you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), and the Current Good Manufacturing Practice (CGMP) regulation for foods, 21 CFR 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 to comply with this section or otherwise operate in accordance with the requirements of 21 CFR 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), Title 21, United States Code (21 USC), Section 342(a)(4). Accordingly, your seafood products are adulterated, because 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 Internet home page at www.fda.gov.

Significant violations were listed on a FORM FDA 483, Inspectional Observations, issued to Mr. Bassett on June 23, 2011, and include, but are not limited to, the following:

1.      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 123.11(b). During the inspection, product residues were observed on many food contact surfaces; employee processing and hand-washing areas; baskets which held processed fish; and, items in the cooler and ice storage area, handled by processing employees.

2.      Failure to maintain building, fixtures, and physical facilities in a sanitary condition and sufficient repair to prevent food from becoming adulterated [21 CFR 110.35(a)]. 

• The refrigeration unit in the ice room is partially detached from the ceiling, dangling from the ceiling, and contacting the ice used on dressed fish.  The walls, ceiling, and interior cooler door of the walk-in cooler had accumulations of product residues.
• The ceiling of the cooler is corroded which prevents effective cleaning and sanitizing of the surface.
• Floors of the cooler, processing room and adjacent room with the three compartment sink had accumulations of product residues and areas of algae or mold growth.

3.   Failure to maintain the plant and grounds in a sanitary manner to prevent product contamination [21 CFR 110.20(a)]. For example, there was a poorly drained, unpaved walkway from the live well building directly into processing area; and, an accumulation of trash and debris next to buildings which can provide a harborage for pests.

4.   Failure to have suitable plant structures [21 CFR 110.20(b)(4)]. For example, the floors of the processing area are not maintained in a manner that allows them to be adequately cleaned. Floor surfaces are eroded to a point where they are pebbled and pitted which precludes effective cleaning and sanitizing. There is an exposed and damaged wood doorway between processing room and walk-in cooler and exposed insulation on the outside of the ice room next to thermometer.

5    Failure to clean all food contact surfaces as frequently as necessary to protect against contamination of the food [21CFR110.35(d)(2)]. For example, there were accumulations of product residue and black mold observed on the interior and exterior surfaces of a green bin used to store skinned catfish. The investigator observed a build up of dried fish residue on wires and crevices of a wire basket used to hold fish prior to weighing.

6.  Failure to maintain all non-food contact surfaces of equipment used in the operation of food plant to be cleaned frequently as necessary to protect against contamination of food [21 CFR 110.35(d)(3)]. For example, the handle of the ice shovel is dirty with an accumulation of product residue. There was an accumulation of filth and product residue on underside surfaces of processing area sink and the floor and pipes under sink.  The band saw used for heading catfish had accumulations of product residue along the sides of the machine and under the work surface, in addition to areas of corrosion which prevent effective cleaning and sanitizing.

7.  Failure to maintain the plant’s restroom in a clean and sanitary manner [21 CFR 110.37(d)]. For example, floors, pipes, and toilet had visible accumulation of a film.

8. Failure to minimize the development of odor, minimize the potential for waste to become a pest attractant or harborage area, and the protection against the contamination of food products [21 CFR 110.37(f)]. For example, fish offal was stored in open, dirty plastic barrels in the cooler with finished products. The barrels show an accumulation of filth on the interiors and exteriors. The walls adjacent to barrels are covered with splash from the offal stored in the barrels.

9.  Failure to handle work-in-process in a manner which protects against product contamination [21 CFR 110.80(b)(5)]. For example, perforated plastic baskets and wire baskets used to hold skinned catfish were observed in direct contact with the wet processing room floor. Baskets have openings on the bottom which allow fish to come in direct contact with the floor or water on the floor.  A green plastic bin covered with a piece of white paper, containing skinned catfish was stored directly on the floor of the cooler.  Perforated plastic baskets of skinned catfish were placed directly next to dirty basket used to hold fish offal.

FDA acknowledges the corrective actions you have voluntarily taken, such as signing your HACCP plan; cleaning the facility; and, obtaining signatures of fish suppliers on the supplier guarantee.

We may take further action if you do not promptly correct all of the noted violations. For instance, legal actions may include product seizure or injunction. You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the specific steps you have taken to correct the noted violations. You should include in your response documentation such as HACCP and verification records, or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections within 15 days, 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 your processing plant operates in compliance with the Act, the seafood HACCP regulations (21 CFR 123) and the CGMP regulation (21 CFR 110). You have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Please send your reply to the U.S. Food and Drug Administration, Attention: Kari L. Batey, Compliance Officer at the above address. If you have questions regarding any issues in this letter, please contact Ms. Batey at (615) 366-7808.

Sincerely, 

/S/ 

Patricia K. Schafer

District Director

New Orleans District

-

Van Deurzen Dairy, LLC 11/25/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700         FAX: (513) 679-2761

 

                                                                                                                                                                               

WARNING LETTER

CIN-12-231014-03

 

October 25, 2011

 

Via United Parcel Services

                                                                                                     

 

Walter A. Van Deurzen, Owner

Van Deurzen Dairy, LLC

2500 County Road 110

Alger, Ohio 45812

 

Dear Mr. Van Deurzen:

 

On July 12 and 14, August 30, and September 2, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 2500 County Road 110, Alger, Ohio. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov. 

 

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

 

Specifically, our investigation revealed that on or about March 22, 2011, you sold a dairy cow, identified with ear tag (b)(4) for slaughter as food.  On or about March 23, 2011, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.43 parts per million (ppm) of penicillin in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

 

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

 

We also found that you adulterated the new animal drug, Penicillin Injection (b)(4) Specifically, our investigation revealed that you did not use penicillin as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).

 

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. 

 

Our investigation found that you administered penicillin to dairy cows without following the dose and duration of treatment as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of penicillin resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).

 

The above is not intended to be an all-inclusive list of violations.  As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

 

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction. 

 

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

 

Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 Extension 2134.

 

Sincerely yours,

/S/

Jane M. Kreis

Acting District Director

Cincinnati District

 

 

cc:   

Dr. Tony Forshey, Acting Chief

Ohio Department of Agriculture

8995 East Main Street

Reynoldsburg, Ohio 43068-3399

Sea Fare Foods, Inc. 10/24/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Detroit District 300 River Place Suite 5900 Detroit. MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139

 

WARNING LETTER

2012-DET-04

 

 

October 24, 2011

 

VIA UPS

 

 

Mr. Philip M. Sack, Owner

Sea Fare Foods, Inc.

2127 Brewster Street

Detroit, MI 48207

 

Dear Mr. Sack:

 

We inspected your seafood processing facility, located at 2127 Brewster St., Detroit, MI 48207 on September 12, 14, 21 and 30, 2011. We found that you have serious violations of the Fish and Fishery Products 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 & 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 hot smoked, vacuum packaged, refrigerated fish products 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 in FDA's home page at www.fda.gov.

 

Your 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 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,

 

a.  Your firm’s HACCP plan(s) for your refrigerated, vacuumed packaged, cooked, ready-to-eat, hot smoked whitefish, sable, salmon, trout, and does not list the food safety hazard(s) of Clostridium botulinum.  

 

b.  Your firm’s HACCP plan for your refrigerated, vacuumed packaged, cooked, ready-to-eat, hot smoked herring does not list the food safety hazards of Clostridium botulinum and Scombrotoxin (Histamine) formation.

 

c.  Your firm’s HACCP plan for your “Pickled Ocean Herring in glass jars” does not list the food safety hazard of allergens, specifically milk.

 

2.  You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor exclusion of pests and the prevention of cross-contamination from insanitary objects to food, food packaging material, and other food contact surfaces, including utensils, gloves, and outer garments, and from raw product to cooked product with sufficient frequency and accuracy to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by:

 

a.  Live insects were observed in the product room by our investigators on September 12 and 14, 2011; however your “Weekly Sanitation Form” for the week ending September 16, 2011, indicates “NO PESTS ARE IN THE PRODUCT AREA” for both these days.

 

b.  Our investigators observed that the same buckets filled with hot water, which were used to rinse the white cloths used to wipe the rims of the uncapped glass gars of ready-to eat creamed herring, where also used to clean the employees hands.

 

We may take further action if you do not promptly correct these violations. For instance, we may take further 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, 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, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). 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: Steven B. Barber: Director, Compliance Branch, 300 River Place,  Suite 5900, Detroit, MI 48207.   If you have questions regarding any issues in this letter, please contact Mr. Barber at 313-393-8110.

 

Sincerely,

/S/

Glenn T. Bass

District Director

Detroit District Office

Medical Compression Systems 10/21/11

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

 

October 27, 2011

 

 WARNING LETTER

 

VIA UNITED PARCEL SERVICE

 

Adi Dagan

Chief Executive Officer

Medical Compression System (DBN) Ltd.

2 Hailan St.

P.O. Box 75

Or-Akiva 30600, Israel

 

Dear Mr. Dagan:

 

During an inspection of your firm located in Or-Akivaon June 20, 2011, through June 23, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the ActiveCare DVT and the ActiveCare + SFT.  Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.

 

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. 

 

We received a response from your firm dated July 12, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:

 

1.    Failure to establish and maintain adequate procedures for the identification, documentation, validation, or where appropriate, verification, review and approval of design changes before their implementation, as required by 21 CFR 820.30(i). For example: the device design was revised to include an (b)(4) for both the ActiveCare DVT and ActiveCare+SFT devices. Your firm’s design validation report No.71365539, Safety Technical Report OVP, includes design verification test results where the device was tested at (b)(4) but does not appear to include testing of production units under actual or simulated conditions as indicated in your Design Verification and Validation procedure referenced in your Design Changes Procedure.

 

The adequacy of the response cannot be determined at this time. Your firm provided documentation for a retrospective analysis and a research and development report based on previous data obtained from (b)(4) as well as a plan for implementation. However, your firm did not provide a copy of the design master validation or documentation of the systemic corrective action.

 

2.    Failure to adequately review, evaluate, and investigate complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c). For example: Complaint No. 09013, dated 07/14/09, describes an event where (b)(4) and attributed the failure to (b)(4). Complaint No.09025, dated 01/11/09, states that the (b)(4). Your firm provided power supply replacements for both occurrences. However, your firm did not conduct an investigation to determine whether the (b)(4) associated with the unit was faulty and did not cause the units (b)(4).

 

The adequacy of the response cannot be determined at this time. Your firm opened CAPA No. 141 to address the need to investigate complaints received. Per this CAPA your firm revised the Complaint Handling procedure, R-QAP014-2, the complaint investigation form, and the Product Experience Form. However, documentation for the implementation of these changes at your firm and distribution level was not provided.

 

3.    Failure to establish and maintain adequate procedures to ensure all complaints are processed in a uniform and timely manner, as required by 21 CFR 820.198(a)(1). For example: Section 5.1 of document R-QAP-14-2-R07, titled Handling Complaints, states (b)(4). However, complaints numbers CC1022, CC1023, and CC1029, were created on 1/23/2011, 3 months after the complaint date and on product receipt date 10/11/2010 and 10/12/2010.

 

The adequacy of the response cannot be determined at this time. Your firm opened CAPA 131 to address the nonconformity by revising the complaint handling procedure (R-QAP-14-2) and MCS Returned Goods Authorization procedure. Per these procedures, complaints are to be created at the receipt of a complaint by any MCS employee. Additionally, your firm has identified a (b)(4) as the decided person to facilitate the recording of complaints. However, your firm did not provide a copy of these revised procedures and has not described how the (b)(4)interacts with other CMS employees when processing complaints.

 

4.    Failure to establish and maintain adequate procedures to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example: your firm issued seven consecutive requests for Corrective and Preventive Action (CAPA) for subcontractor (request 5-11) to (b)(4) pertaining to the (b)(4) from 7/08 to 5/09. Specifically, in section 6.4 of Document No. R-QAP-14-1-R04, it is stated that (b)(4).   Following, in section 6.5, it is stated that (b)(4)  In request No. 006, Request for Corrective/Preventive Action for Subcontractor, the recommended corrective/preventive action is stated to be  (b)(4) As such your firm has failed to adequately identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems.

 

We reviewed your firm’s response and conclude that it is not adequate. Your firm provided memoranda indicating that the seven subcontractor Corrective action requests had been closed out due to the removal of (b)(4) from the Approved Vendor List. Additionally, your firm stated that it will conduct a retrospective review of all supplier corrective actions over a period of 12 months to ensure that they were all adequately closed, to be completed by October 2011. However, your firm has not addressed whether a plan will be implemented to address the adequacy of closed CAPAs from other sources or quality data.

 

5.    Failure to establish and maintain adequate procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example: (b)(4).

 

The adequacy of the response cannot be determined at this time. Your firm provided records of quality audits based on a full quality system assessment conducted on May 2011. Additionally, your firm revised the Management Review Procedure, R-QAP-01-1-R06, to require that Management Reviews cannot be finalized without having a report of the results of each quality audit. The next management review will occur in Q3-2011 and in Q1-2012. Your firm did not provide copies of this corrective action.

 

6.    Failure to establish and maintain adequate procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a). For example: (b)(4).

 

The adequacy of the response cannot be determined at this time. Your firm provided revised copies of its Statistical Techniques Procedure, R-QAP-20-1, to include sample size requirements for quality inspections based on ANSI Z1.4 Sampling Tables for Inspection by Attributes. Per this revision, your firm plans to revise its work instructions to identify which AQL will be used for acceptance. Your firm did not provide documentation to demonstrate that these requirements have been implemented in all required Work Instructions, which will ensure that all of your firm’s supplied products are inspected per your firm’s acceptance activities requirements.

 

7.    Failure to maintain records at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections, as required by 21 CFR 820.180. For example: during the inspection, your firm could not locate complaint #0603, including Medical Device Reporting #9616558-2006-00001, regarding a death of a patient that was treated with the Medical Compression System (MCS) ActiveCare DVT System (b)(6). When asked for this file, your firm provided the investigator with a copy of the “MAUDE Adverse Event Report” printed from the FDA’s internet website.

 

The adequacy of the response cannot be determined at this time. Your firm provided revised copies of its Document Control Procedure, R-QAP-05-1, to ensure that all QMS records are organized, contain the appropriate information, and are stored and archived in a known, organized location.  As a corrective action, your firm plans to train personnel, conduct an audit of the record retention policy, including an actual review of archived records, and a simulated retrieval exercise. However, your firm did not provide documentation for the proposed corrective action and has not indicated in the Document Control Procedure provided where these documents will be stored.

 

Our inspection also revealed that your firm’s ActiveCare DVT and the ActiveCare + SFT devices 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 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:

 

Failure to submit a written report to FDA within 10 working days of initiating such correction or removal, as required by 21CFR 806.10(b). For example: (b)(4).

 

We reviewed your firm’s response and conclude that it is not adequate. Your firm conducted a Risk Assessment of the failure mode and submitted an 806 report to the Detroit District Office on 9/25/2011. However, your firm did not define the corrective action, implementation plan, and effectiveness checks to ensure that a correction or removal report is submitted to the agency within the defined timeframe.

 

Our inspection also revealed that the ActiveCare DVT and the ActiveCare + SFT are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency.  [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

 

Specifically, the ActiveCare DVT and the ActiveCare + SFT were cleared under K023573 and K060146, respectively.  Our inspection revealed that your firm modified the devices by (b)(4) to the Active Care DVT and the ActiveCare + SFT (b)(4). A new 510(k) is required for this modification as it represents a significant change to the design of the devices.

 

Given the serious nature of the violations of the Act, the ActiveCare DVT and ActiveCare + SFT devices manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you if your firm’s response appears to be adequate, and we may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.

 

Also, U.S. federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected.  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 business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.  Please provide a translation of documentation not in English to facilitate our review.

 

Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, RM 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #222174 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Vascular and Circulatory Support Devices Branch at (301)796-5587 or fax at (301) 847-8138.

 

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility.  It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems.  Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance. 

 

 

Sincerely yours,

/S/                                                           

Steven D. Silverman

Director

Office of Compliance

Center for Devices and

    Radiological Health

Hanover Foods Corporation 10/21/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410)779-5454 FAX: (410) 779-5703

FEI (b)(4)

WARNING LETTER

CMS# (b)(4)

October 21, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. John A. Warhime, CEO/Chairman
Hanover Foods Corporation
P.O. Box 334
Hanover, Pennsylvania 17331

Dear Mr. Warhime:

The Food and Drug Administration (FDA) conducted an inspection of your produce manufacturing facility, located at 502 Factory Lane, Hanover, Maryland from April 6 to April 30, 2009 and from May 11 to May 27, 2010.  During the inspection, FDA collected a number of samples. Laboratory analyses of these samples found the presence of the pathogen Listeria monocytogenes (L. mono) in environmental and in-line samples.  In addition, FDA investigators documented serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). These observations and the results of the laboratory analysis cause the foods manufactured at your facility to be adulterated under 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act (the Act), in that they were 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 and FDA’s regulations through links in FDA’s home page at http://www.fda.gov.

During the inspection, FDA collected samples of in-line sliced mushrooms, and environmental swabs and sponges taken from throughout your processing facility, including the Individually Quick Frozen (IQF) room. Laboratory analysis of the samples confirmed the presence of L. mono in a sliced mushroom in-line sample and in an environmental sample from a food contact surface.  The finding of L. mono in a sliced mushroom in-line sample, and on food contact surfaces in your facility indicates a high risk of finished product contamination.

L. mono is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility.  L. mono can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Listeriosis is an atypical foodborne illness of major public health concern because of the severity of the disease, a high case-fatality rate, a long incubation and a predilection for individuals with underlying conditions.

Our investigators documented a number of significant objectionable conditions relating to your facility’s compliance with the CGMP regulations.  Significant deviations observed during the inspection include:

1. Your firm failed to take effective measures to protect finished food from contamination by ingredients or refuse, and failed to protect food transported by conveyor against contamination as required by 21 CFR 110.80(b)(6). Specifically, the following was observed during the inspection:

A. Ready-to-eat mushrooms were observed spilling from the hopper affixed to the conveyer belt in the IQF room onto an electrical panel accumulated with old food debris.  After the mushrooms spilled onto the electrical panel accumulated with old food debris they bounced into a 40lb box containing ready-to-eat mushrooms.

B. Accumulated mushroom debris was observed caught between the conveyer belt and conveyer belt wheel. The accumulated mushroom debris was observed being sprinkled into open boxes containing ready-to-eat mushrooms in the IQF room.

C. Defrosted mushroom debris was observed accumulated on the following pieces of equipment during operation and coming in contact with the rotating conveyer belt carrying ready-to-eat mushrooms to be packed: 

  a) Cross beam beneath the magnet as mushrooms exit from the IQF freezer.
  b) Scraper located beneath the magnet as mushrooms exit from the IQF freezer.
  c) Metal guide affixed to magnet as mushrooms exit from the IQF freezer.

2. Your firm failed to take effective measures to protect against the inclusion of metal or other extraneous material in food as required by 21 CFR 110.80(b)(8). Specifically, an accumulation of rust was observed on multiple bolts affixed to a grow rack containing wheat grass in the “Green Sprout Grow Room.”  The bolts were observed to be dripping water that accumulated on them from the grow rack's watering system.  The rusty bolts were located directly over multiple pans containing in-process (growing) wheat grass.

3. Your firm failed construct your facility in such a manner that drip or condensate from fixtures 

does not contaminate food as required by 21 CFR 110.20(b)(4). Specifically, two 55 gallon drums that contained ready-to-eat alfalfa sprouts were observed stored uncovered under a water hose reel that was affixed to the wall of the “Sprout Washroom.” The water hose reel was accumulated with water and water droplets were observed dripping into the drums that contained uncovered ready-to-eat alfalfa sprouts.

4. Your firm failed to provide adequate screening or other protection against pests as required by 21 CFR 110.20(b)(7). Specifically, the following was observed during the inspection:

A. The receiving door located on the western wall of the “Dry Warehouse” had three gaps leading to the exterior of the firm.

B. The northern wall of the “Green Bean Room” had a gap which led to the exterior of the firm.

C. The exit door on the southern wall of the “Green Bean Room” had a gap which led to the exterior of the firm.

We have reviewed your June 9, 2010 response letter to the FDA-483 from Bridget Dadds, QC Management. Although your letter states that a number of corrective actions have been completed, the actions outlined in your response letter have not fully addressed all our concerns.  Please submit documentation which shows completion of corrections (i.e., revised SSOPs, photographs or receipts that verify equipment or other structural modifications, etc.) and steps you have taken to prevent contamination of finished products with L. mono. The adequacy and implementation of your corrective actions and will be assessed during our next inspection.

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 CGMP regulations (21 CFR Part 110). You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice, including seizure and/or injunction.
We request that you notify this office in writing, within 15 working days from your receipt of this letter, of the current status of your corrective actions since your June 2010 correspondence, including any further specific steps that you have taken to correct violations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining violations.

Please send your reply to the Food and Drug Administration, Attention: Randy F. Pack, Compliance Branch Director at the address above.  If you have questions regarding any issues in this letter, please contact Mr. Pack at (410) 779-5417.
Sincerely,
/s/
Evelyn Bonnin
District Director

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