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WARNING LETTER

Pierless Fish Corp. MARCS-CMS 515899 —

Delivery Method:
United Parcel Service
Recipient:
Recipient Name
Robert W. Demasco
Pierless Fish Corp.

5600 First Avenue, Unit B9
Brooklyn, NY 11220
United States

Issuing Office:
New York District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
New York District
158-15 Liberty Ave
Jamaica, NY 11433 

 

DATE: January 26, 2017
 
WARNING LETTER NYK-2017-3
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Robert W. Demasco, President
Pierless Fish Corp.
5600 First Avenue, Unit B9
Brooklyn, NY 11220
 
Dear Mr. Demasco:
 
We inspected your seafood processing and importer establishment, located at 5600 First Avenue, Unit B9, Brooklyn, NY 11220 between November 29, 2016 through December 5, 2016. 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 refrigerated, ready-to-eat, pasteurized canned crabmeat and imported Sea bass and Sea bream 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 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 your refrigerated, ready-to-eat, pasteurized canned crabmeat. 
 
2.    You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the aquacultured Sea bass imported from (b)(4) and the aquacultured Sea bass and aquacultured Sea bream imported (b)(4). 
 
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
 
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.
 
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.
 
Section 743 of the Act, (21 USC 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 non-compliance 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 USC 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.
 
Your written response should be sent to W. Martin Rennells, Compliance Officer, U.S. Food and Drug Administration, One Winner's Circle, Suite 110, Albany, New York 12205. If you have any questions about this letter, please contact Compliance Officer W. Martin Rennells at (518) 453-2314 ext. 1038 or by e-mail at william.rennells@fda.hhs.gov.
  
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District
 
 
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