A Dec. 2nd warning letter from the U.S. Food and Drug Administration (FDA) to Fort Bragg, CA-based Ocean Fresh LLC says the seafood processing facility is producing ready-to-eat raw sea urchin that is adulterated.

FDA said it inspected the Fort Bragg facility over several days last August and September and found “serious violations” of both the seafood Hazard Analysis and Critical Control Point and Current Good Manufacturing Practice regulations.  

Ocean Fresh is a privately held seafood wholesaler with annual sales in the $20- to $50 million range, according to the Manta business directory.  

FDA said that among Ocean Fresh’s significant violations were:

  • No consistent record-keeping system.

  • Not monitoring procedures at the frequency listed in its HACCP plan.

  • The corrective action plan to controlling pathogens was not appropriate.

  • Sanitation control records were not being maintained.

  • Water safety, condition and cleanliness of food contact services, and cross-contamination were not being properly monitored.

FDA said none of the seafood processing facility’s water hoses was equipped with backflow prevention devises and plastic totes for the sea urchins were being rinsed with the same harbor water where seals and birds were swimming.

Investigators also found problems with the use of utensils, gloves, and outer garments, including the use of reusable gloves that were in contact with urchins, ready-to-eat urchin, and processing water.

“You should respond in writing within fifteen (15) working days from your receipt of this letter,” FDA wrote the company.  “You should include in your response documentation such as a HACCP and verification records, or other useful information that would assist us in evaluating your corrections.”

FDA said that it might take further action if the corrections were not made.  “For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating,” the warning letter says.

Ocean Fresh annually provides jobs to 20-49 people, according to Manta.