The Paul W. Marks Company, Inc., a 50-year old family-owned food distributor in Everett, MA has a problem with the U.S. Food & Drug Administration (FDA).
It is making ready-to-eat chowder that is adulterated, according FDA, because “it may have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.”
Marks got a Dec. 21st “Warning Letter” from New England District Director John R. Marzilli about the violations that was made public this week by FDA.
FDA spent four days inspecting the Marks Company last Sept. 15th and 16th and Oct. 8th and 9th. “We found, ” Marzilli wrote, “that you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, 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)…”
FDA told the Marks Company that it “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 a written HACCP plan to control any food safety hazards…”
The Marks Company, according to FDA, does not have a HACCP plan for its refrigerated ready-to-eat chowder to control the food safety hazard of pathogen growth and the potential for toxin formation, including botulism.
FDA told the Marks Company that if it does not correct its violations, the federal government might take further action. Marks has 15 working days to respond to FDA’s “Warning Letter.”
In addition to the HACCP regulations, FDA told the Marks Company it is responsible for compliance with the Current Good Manufacturing Practice regulations.