|Company:||Jersey Lynne Farms, Inc.|
|Subject:||CGMP for Foods/Seafood HACCP/Adulterated|
|Issuer:||New York District Office|
|Issued:||Feb. 14, 2006||Closed:||
Department of Health and Human Services
Public Health Service
New York District
RETURN RECEIPT REQUESTED
February 14, 2006
Mr. Michael Loconte
Jersey Lynne Farms, Inc.
8801 Foster Avenue
Brooklyn, NY 11236-3210
Dear Mr. Loconte:
We inspected your seafood processing facility, located at 8801 Foster Avenue, Brooklyn, NY on December 19 & 22, 2005. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice regulation for foods, 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).
In addition, as an importer of fish or fishery products, you must operate in accordance with the special requirements for importers set forth in Part 123.12. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.
Accordingly, your vacuum packed pickled split mackerel and smoked herring fillets 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:
You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However your firm does not have a HACCP plan for vacuum packed pickled split mackerel and smoked herring fillets to control the food safety hazards of scombrotoxin formation (histamine) and pathogen growth and, additionally for the vacuum packed pickled split mackerel, to control the food safety hazard of Clostridium Botulinum toxin formation.
You must maintain sanitation control records that, at a minimum, document monitoring and corrections to comply with 21 CFR 123.11(c). However your firm did not maintain sanitation monitoring records for safety of the water that comes into contact with food or food contact surfaces, or is used in the manufacture of ice; condition and cleanliness of food contact surfaces, including utensils, gloves, and outer garments; 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; maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; proper labeling, storage, and use of toxic compounds; control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces; and exclusion of pests from the food plant required for the processing of vacuum packed pickled split mackerel and smoked herring fillets.
You must have written verification procedures that include product specifications and the affirmative step to be implemented and that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i) and (ii). However, your firm does not have written verification procedures for vacuum packed pickled split mackerel and smoked herring fillets from Canada.
We may take further action if you do not promptly correct these violations . For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
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 seafood importer establishment and processing plant operate 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 for the fish or fishery products that you process and import into the United States.
Please send your reply to: the U.S. Food and Drug Administration, New York District, 158-15 Liberty Avenue, Jamaica, New York 11433, Attn: Anna Alexander, Compliance Officer, HFR-NE 140.
If you have questions regarding any issues in this letter, please contact Ms. Alexander at (718) 340-7000 ext. 5683.
Joseph F. McGinnis
Acting District Director