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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hyson USA Inc 21-Aug-07

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863


WARNING LETTER
CHI-7-07

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

August 21, 2007

Leonid M. Tansky, President
Hyson USA, Inc.
2484-2486 E. Oakton Street
Arlington Heights, Illinois 60005-4820

Dear Mr. Tansky:

We inspected your seafood processing and importer establishment, located at 2484-2486 E. Oakton
Street, Arlington Heights, Illinois on May 17, 21, and 23, 2007. 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 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 this part, 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). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. 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 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 cold smoked vacuum packed butterfish is adulterated in that it has been prepared, packed, or held under insanitary conditions whereby it 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 violation was as follows:

• 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 cold smoked vacuum packed butterfish to control the food safety hazard Clostridium botulinum.

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 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). 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.

Your response should be sent to: Patrick J. Brown, Compliance Officer, Food and Drug Administration, 550 West Jackson Boulevard, 15th Floor, Chicago, Illinois 60661-5800.

Sincerely,

/S/

Scott J. MacIntire
District Director

cc: Mr. Karolis Kaminskas, Secretary/Co-Owner
Hyson USA, Inc.
2484-2486 E. Oakton Street
Arlington Heights, Illinois 60005-4820