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U.S. Department of Health and Human Services

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Enforcement Actions

Belford Seafood Co-Op 31-Oct-07

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

Public Health Service
Food and Drug Administration

 

Central Region
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Telephone (973) 331-4904
Parsippany, NJ 07054


October 31, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

File #08-NWJ-02

Mr. Roy Diehl
President
Belford Seafood Co-Op
901 Port Monmouth Road
Belford, New Jersey 07718

Dear Mr. Diehl:

We inspected,your seafood processing facility, located at 901 Port Monmouth Road, Belford, New Jersey, on September 24, 2007 through October 2, 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, 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). 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 implement the monitoring procedure and frequency that you have listed in your HACCP plans, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement your listed monitoring procedures at the receiving and storage critical control points (CCPs) to control the food safety hazard of histamine formation, as listed in your HACCP plans for Pound Fishing and Harvest Vessels. Specifically, you received fresh bluefish, mackerel, shad, skipjack, and herring from pound nets and harvest vessels on at least 9 distinct occasions from April 22, 2007 through August 27, 2007. Your firm performed no monitoring activities at the receiving or storage CCPs during this time period.

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 be re 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 processing plant 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.

Your response to this letter should be directed to the U.S. Food and Drug Administration, Attention: Andrew Ciaccia, Compliance Officer at the address and telephone number listed above.

Sincerely,

/S/

Douglas I. Ellsworth
District Director
New Jersey District

Cc: Mr. Joseph M. Branin
General Manager
901 Port Monmouth Road
Belford, New Jersey 07718