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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Atlantic Coast Seafood Inc. 02/18/2009

   

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

Public Health Service
Food and Drug Administration
  New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896



 

WARNING LETTER

NWE-06-09W

February 18, 2009

VIA Federal Express

Salvatore Bramante, President, Co-owner
Atlantic Coast Seafood Inc.
42-44 Boston Fish Pier
Boston, Massachusetts 02210

Dear Mr. Bramante:

We inspected your seafood processing facility, located on 4-44 Boston Fish Pier, Boston, Massachusetts, on October 22, 28, 29, 30, November and 14, 2008. 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, 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 bluefish 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 violations were as follows:

1. To comply with 21 CFR 123.6(c)(3), you must have a HACCP plan that, at a minimum, lists the critical limits that must be met at each Critical Control Point (CCP). 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."

Your firm's HACCP plan for bluefish lists the critical limits at the Receiving CCP as: (b)(4) . These critical limits are not adequate to control the hazard of histamine formation in bluefish when your firm acts as a primary processor receiving bluefish directly from the harvest vessels. For example, your critical limit for decomposition fails to define the minimum value at which you would reject a lot of fish. FDA recommends a critical limit of 2.5% decomposition because if a greater percentage of the sample exhibits odors of decomposition, this may indicate that the lot of fish may not have been handled in a safe manner aboard the harvest vessel, and you should consider rejecting the entire lot. FDA also recommends that you sample a minimum of 118 fish for decomposition or sample the entire lot if less than that amount is received.

In addition FDA recommends, as a primary processor, that you implement one of the following critical limits at your Receiving CCP:

a. Require harvest vessel records that show that the fish were handled in accordance with the on board controls recommended in the FDA Fish & Fisheries Products, Hazards & Controls Guidance, Third Edition; or

b. Conduct histamine analysis of a representative number of fish in each lot with a maximum allowable limit of <50 ppm. FDA currently recommends that analysis be performed on a minimum sample of 18 fish per lot.

2. You must have and implement a recordkeeping system to document the monitoring of each CCP, including the actual values and observations obtained during monitoring, to comply with 21 CFR 123.6(b) and 123.6(c)(7). However, your firm did not maintain records of all of its monitoring observations at the Cold Storage CCP to control the food safety hazard of histamine formation. Specifically, your records did not document the monitoring of the adequacy of ice two times daily.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

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 verification records, 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 facility operates in compliance with the Act, 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.

Please send your reply to the Food and Drug Administration, Attention: Bruce R. Ota, Compliance Officer, One Montvale Avenue, Stoneham, Massachusetts, 02180. If you have questions regarding any issues in this letter, please contact Mr. Ota at 781-596-7762.

Sincerely,

/S/

John R. Marzilli
District Director
New England District

cc: Bernard Bramante, Jr., Co-owner
Atlantic Coast Seafood Inc.
42-44 Boston Fish Pier
Boston, Massachusetts 02210