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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Preferred Freezer Services, Inc. 26-Jun-07

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

Public Health Service
Food and Drug Administration

 

Central Region
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone (973) 331-4908


June 26, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. John J. Galiher
President
Preferred Freezer Services, Inc.
350 Avenue P
Newark, New Jersey 07105

File# 07-NWJ-12

Dear Mr. Galiher:

We inspected your seafood processing facility, located at 231 Elm Street, Perth Amboy, New Jersey, on May 1, 3, 8, 9 and 10, 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). Accordingly, your canned, pasteurized crab meat 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 implement the monitoring procedure and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement your listed monitoring procedure of obtaining container temperature recording records at the receiving critical control point to control Clostridium botulinum toxin formation listed in your HACCP plan for Canned Pasteurized & Smoked Vacuum Packed Products. Specifically, an FDA investigator documented your receipt of canned pasteurized crabmeat shipped from the [redacted] and [redacted] on at least thirteen distinct occasions from February 2, 2007 through April 27, 2007.

Your firm did not obtain time/temperature data records to assure that the product was maintained at 40°F or less throughout the transportation process for any of these shipments, as specified in your plan. FDA does not consider monitoring product temperatures upon arrival an adequate method of assuring that safe conditions have been maintained throughout transit/shipment when transit times are greater than four hours.

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 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: Richard D. Manney, Compliance Officer at the address and telephone number listed above.

Sincerely,

/S/

Douglas I. Ellsworth
District Director
New Jersey District