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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Eagle New York 12/6/13

  

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

Public Health Service
Food and Drug Administration
 New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, New Jersey 07054
Telephone: (973) 331 - 4900
FAX: (973) 331- 4969

December 6 , 2013
 

WARNING LETTER

VIA-UPS OVERNIGHT

Mr. Sebastian Kulagowski, Owner
Mr. Peter Wilk, Owner
Eagle New York
70 Outwater Lane
Garfield, NJ 07026
 

File No. 14-NWJ -03
 

Dear Messrs. Kulagowski and Wilk,

We inspected your seafood processing facility, located at 70 Outwater Lane, Garfield, NJ 07026 on October 19 and October 22, 2013. We found that you have a serious violation 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). Accordingly, your herring 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 violation is 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). A food safety hazard is defined in 21 CFR 123.3 (f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However your firm does not have a HACCP plan for your herring products in order to control the hazards of scombrotoxin (histamine) formation and pathogen growth and toxin formation. On October 22, 2013, an investigator observed the following herring products stored under refrigeration at your facility: extra-large herring fillets, roll mop herring, creamed herring, Bismark herring, and thick-cut herring.

The violation cited in this letter is not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violation identified above and for preventing the recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.

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 reinspection 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)). 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 take prompt action to correct the violation cited in this letter. Failure to promptly correct the violation may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violation. Include an explanation of each step being taken to prevent the recurrence of the violation, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be addressed to U.S. Food and Drug Administration, 10 Waterview Boulevard, 3rd Floor, Parsippany, New Jersey, 07054, Attn: Kerry Kurdilla, Compliance Officer. 

Sincerely,

/S/
Diana Amador-Toro
Director
New Jersey District