Inspections, Compliance, Enforcement, and Criminal Investigations
Catso Corp. 26-Sep-06
Department of Health and Human Services
Public Health Service
158-15 Liberty Avenue
September 26, 2006
WARNING LETTER NYK 2006-27
RETURN RECEIPT REQUESTED
Robert L. Simon, President
25 Myers Road
Wallkill, NY 12589-3516
Dear Mr. Simon:
We inspected your seafood processing facility, located at 25 Myers Road, Wallkill, NY on August 24 and 29, 2006. 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 (21 CFR 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 fish terrine 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 have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(b). However your firm does not have a HACCP plan for the refrigerated, ready to eat, vacuum packaged fish terrine products to control the hazard of Clostridium botulinum toxin formation.
2. You must have product specifications 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). However, your firm does not have written product specifications for imported ready to eat, vacuum packaged fish terrine products.
3. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for ready to eat, vacuum packaged fish terrine products.
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. § 38 1(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 importer verification records and records that document the performance and results of your firm's affirmative steps, 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 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 for the fish or fishery products that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Richard T. Trainor, Compliance Officer, 300 Hamilton Ave., White Plains, NY 10601. If you have questions regarding any issues in this letter, please contact Mr. Trainor at 914-682-6166 extension 34.
Otto D. Vitillo