Two California seafood processing facilities, one making corn clam chowder in Irvine, and the other preparing tuna and mahi-mahi in Bell, recently received warning letters from the U.S. Food and Drug Administration (FDA).

Village Green Foods Inc.’s chowder and R&P Seafood Corp.’s tuna and mahi-mahi were being made without seafood Hazard Analysis and Critical Control Point (HACCP) plans, according to the FDA warning letters.

In an Aug 9 warning letter to Village Green Foods, FDA said the Irvine seafood processor does not list botulism and allergens as food safety hazards in its plan. It said the company promised to provide a revised plan in its written response to the FDA inspection observations, but has not done so.

The corn clam chowder is packaged in oxygen-impermeable plastic bags.  FDA is concerned about adequate cooking times and temperatures and wants the company to do 24/7 monitoring and recording.

In an Aug. 16 warning letter, FDA says R&P Seafood has “serious violations” of the seafood HACCP regulations that render its fish products to be “adulterated” under the law.

“Accordingly, your histamine forming species including Tuna and Mahi-Mahi are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health, ” the warning letter says.


Certain bacteria form histamines, which are common in salt water and exist harmlessly on some fish until they die, but then grow into scrombotoxins that can make consumers sick.

During its inspection last April 9, FDA personnel said, “multiple tuna fillets were observed in the cooler that were not covered in ice.”  Investigators also found that temperatures were not always being recorded.

FDA also charged R&P Seafood with not complying with sanitation requirements, including the safety of the water, keeping food contact surfaces clean, preventing cross-contamination, maintaining hand washing and toilet facilities, protecting packaging from adulteration, proper labeling, storage and use of toxic chemicals, exclusion of pests and controlling employee health conditions.

FDA said the seafood processor’s corrective action plan for scombrotoxin-producing fish at the receiving point to control histamine formation “is not appropriate.”  

It said the company must verify the calibration of process monitoring instruments, and do a better job of monitoring.


The California seafood processing companies were asked to respond to their FDA warning letters within 15 business days.