FDA WARNING_LETTER - Paul W. Marks Co., Inc - October 09, 2009

On December 21, 2009, the FDA issued a Warning Letter to Paul W. Marks Company Inc. following an inspection of their food distribution facility in Everett, MA, conducted on September 15, 16, and October 8, 9, 2009. The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The primary violation identified was the firm's failure to have a written HACCP plan for its refrigerated ready-to-eat clam chowder. This omission means the company has not adequately controlled the food safety hazard of pathogen growth and potential toxin formation, specifically Clostridium botulinum toxin, at critical control points such as receiving and storage. This renders the clam chowder adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as it may have been prepared, packed, or held under insanitary conditions.

The FDA requires the firm to promptly correct these violations. Failure to do so may result in further action, including product seizure and/or injunction against the firm's operations. A written response outlining specific corrective actions, including the HACCP plan for ready-to-eat clam chowder, was required within fifteen working days of receiving the letter. The letter also emphasized the firm's ongoing responsibility to comply with the Act, Seafood HACCP regulation,