FDA issued Warning Letters to two seafood processing facilities for selling adulterated products under the seafood Hazard Analysis and Critical Control Point (HACCP) regulation:  Pulmuone Foods USA, Inc. in Fullerton, CA and 17 Merrill Drive, LLC in Rockland, ME.

Under the HACCP regulation, a seafood processing facility must have an annually signed and dated HACCP plan.  The HACCP plan must contain the appropriate "critical limits" which are measured and verified.  These would include, for example, temperature control measures that are monitored with calibrated instruments, and a list of the food safety hazards of pathogens caused by time and temperature abuse, and undeclared allergens.  A food safety hazard is defined as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." 

Seafood products at these two facilities were deemed adulterated because both failed to properly document, implement, and monitor their respective HACCP plans.  Further, 17 Merrill Drive LLC violated Current Good Manufacturing Procedures (CGMP) for Human Food, 21 C.F.R. 110, because it failed to monitor:  the cleanliness of food contact surfaces, the prevention of cross-contamination from insanitary objects, and the protection of food contact surfaces from adulteration with chemical, physical, and biological contamination.  FDA found issues with steam condensation generated by the cooking process that was dripping from the ceiling into the raw area due to inadequate exhaust/ventilation; discolored and rusty ice chute; and cleaning hoses in direct contact with wet processing room floors in the raw and high risk areas when not in use.

Warning Letters issued to food processing facilities

FDA issued a Warning Letter to a food processing facility, Bluegrass Holdco, Inc. in Stamford, CT, for manufacturing adulterated food products and violating the CPMG for Human Food.

Investigators identified the presence of salmonella at the Bluegrass Holdco, Inc. and determined that the food products processed at this whey powder manufacturing facility were adulterated in that they have been "prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or whereby they may have been rendered injurious to health."

The FDA noted that this was a repeated salmonella finding at this facility.  While Bluegrass Holdco, Inc. had offered in its response that it had shut down and was thoroughly cleaning the facility, and had hired a third-party consultant to investigate the contamination problem, FDA replied that the response lacked further detail about the specific corrective actions the facility has taken or will take, and the explanation of their appropriateness.

Companies in receipt of a Warning Letter have 15 days to respond to the agency, in writing, to explain the steps taken to correct the violations.  The FDA then evaluates the responses and, if needed, can take regulatory action without further notice, such as seizure, injunction, or the initiation of administrative enforcement procedures. 

More information can be found here.