Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
November 4, 2015
WARNING LETTER NYK-2016-6
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUEST
Mr. Grigoriy Katsura, President
Krasnyi Oktyabr USA Inc.
Sunset Industrial Park
60 20th Street
Brooklyn, NY 11232-1101
Dear Mr. Katsura:
We inspected your seafood processing and importer establishment, located at Sunset Industrial Park, 60 20th Street, Brooklyn, NY 11232-1101 on June 15-16, 2015, and again August 5 and August 7, 2015. 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 Part123. 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 dried salted sprats, dried salted horse mackerel fillets, refrigerated vacuum packaged salted dried bream fish and refrigerated vacuum packaged salted dried Caspian roach (vobla) are adulterated, in that they havebeen 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 a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for refrigerated vacuum packaged salted dried bream fish and refrigerated vacuum packaged salted dried Caspian roach (vobla) lists a critical limit of “At time of receipt the temperature of the truck or reefer container does not exceed 38°F” at your “Receiving Refrigerated Dried Eviscerated Fish in Vacuum Packages” critical control point. This is not adequate to control the hazard of Clostridium botulinum toxin formation.
For delivery of these types of refrigerated products with transit times exceeding 4 hours total cumulative time, all lots received should be accompanied by transportation records that show the product was held at or below 40 degrees Fahrenheit throughout transit.
2. You must make available for FDA review and copying at reasonable times all mandatory records, plans, and procedures required under 21 CFR Part 123 to comply with 21 CFR 123.9(c). However, a representative of your firm was unable to make available for FDA review the receiving records for your refrigerated vacuum packaged salted dried bream fish and refrigerated vacuum packaged salted dried Caspian roach (vobla). In addition, you were unable to provide records of corrective actions when your cooler temperatures exceeded your critical limit on August 1st, 3rd, and 4th, 2015.
3. You must maintain records, in English, that document the performance and results of the affirmative step(s), to comply with 123.12(c). However, your firm has records that are not in English.
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 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.
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)(B)). 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
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, One Winners Circle, Suite 110, Albany, NY 12205, Attention: LCDR Catherine M. Beer. If you have questions regarding any issues in this letter, please contact LCDR Catherine M. Beer at (518)-453-2314 x1015.
New York District