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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Paul W. Marks Co., Inc 12/21/09

   

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-10-10W

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Date: December 21, 2009

Peter W. Marks
Phillip W. Marks
Owners
Paul W. Marks Company Inc.
8 Commercial Street
Everett, MA 02149-5507

Dear Messer’s Marks;

We inspected your food distribution facility, located at 8 Commercial Street, Everett, MA on September 15, 16, and October 8, 9, 2009. 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. 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, the ready-to-eat clam chowder that your firm distributes is adulterated, in that it may have 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 violation is as follows:

1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery products to determine whether there are food safety hazards that are reasonably likely to occur and you must have a written HACCP plan to control any 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 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 clam chowder to control the food safety hazard of pathogen growth and potential toxin formation, including for example Clostridium botulinum toxin formation at the critical control points of receiving and storage.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product 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 your HACCP plan for ready-to-eat clam chowder, 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.

Please send your reply to the Food and Drug Administration, Attention: Anthony P.Costello. If you have questions regarding any issues in this letter, please contact Mr. Costello at 781 596-7716.

Sincerely,

/s/


John R. Marzilli
District Director
New England District