FDA WARNING_LETTER - Bristol Seafood, Inc. - March 21, 2013

On April 16, 2013, the FDA issued a Warning Letter to Bristol Seafood Inc. following an inspection from February 25 to March 21, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The primary violation identified was the firm's failure to have a written HACCP plan to control the hazard of Clostridium botulinum for refrigerated raw scallops packaged in metal cans, similar to paint cans, and distributed on ice. The firm's hazard analysis incorrectly concluded that no hazards were pertinent to their processing steps for fresh and frozen scallops. The FDA determined that an anaerobic environment conducive to botulinum toxin formation was reasonably likely to develop within these non-oxygen permeable containers, especially under time-temperature abuse, despite the firm's acknowledgment of the can's air transmission rate being significantly lower than the FDA's recommended rate.

As a result, the refrigerated and frozen raw shucked scallops were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's April 9, 2013, response to the FDA-483 observations was deemed unacceptable as it lacked scientific evidence or an effectively implemented HACCP plan to prevent C.