- Polonica Inc.
- Issuing Office:
- New Jersey District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New Jersey District Office
Waterview Corporate Center
10 Waterview Blvd. 3th Floor
Parsippany, New Jersey 07054
FAX: (973) 331-4969
June 4, 2014
VIA UNITED PARCEL SERVICE
Mr. Marek Pyrycz
President and Co-owner Polonica Inc.
10 Self Boulevard
Carteret, NJ 07008
Warning Letter No:14-NWJ-06
Dear Mr. Pyrycz
The United States Food and Drug Administration (FDA) inspected your seafood processing and importer facility, located at 10 Self Boulevard, Carteret, NJ 07008 from April 7 through April14, 2014. 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 Part 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 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 products have been processed under conditions 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 Act, 21 U.S.C.§342(a)(4).
Accordingly, your marinated herring with dill cream, marinated herring "homestyle," marinated rollmops herring, vacuum-packed hot smoked mackerel, sprats in oil, and sprats in tomato sauce 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.
We acknowledge your written response dated June 2, 2014. The agency has reviewed your response; however, it does not adequately address the violations as noted below.
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 you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a), and (b). However, your firm does not have a HACCP plan for: marinated herring with dill cream, marinated herring "homestyle," marinated rollmops herring, and vacuum-packed hot smoked mackerel to control the food safety hazards of Clostridium botulinum toxin formation, scombrotoxin (histamine) formation, and pathogen growth and toxin formation.
We reviewed your written response dated June 2, 2014 and determined that it is inadequate because you have not completed and implemented a HACCP plan.
2. You must implement product specifications and 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 does not have product specifications or an affirmative step for your sprats in oil, sprats in tomato sauce, marinated herring with dill cream, or your marinated herring "homestyle" imported from Poland.
We reviewed your written response dated June 2, 2014 and determined that it is inadequate because it does not address this violation.
We may take further action if you do not promptly correct these violations. For instance, we may: 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.
Section 743 of the Act (21 U.S.C.379j-31) authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. A re inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(8)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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) 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 your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Ms. Kerry Kurdilia, Compliance Officer,10 Waterview Boulevard, Suite 300, Parsippany, NJ 07054. If you have questions regarding any issues in this letter, please contact Ms. Kurdilla at (973)331-4908.
Director, New Jersey District
Close Out Letter