Freshwater Fish Products, Inc. – FDA Warning Letter, Feb 6, 2012

On February 2-6, 2012, the FDA inspected Freshwater Fish Products, Inc.'s seafood processing facility in Bradford, Arkansas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's sturgeon and paddlefish roe (caviar) were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

The primary violation identified was an inadequate HACCP plan for sturgeon and paddlefish roe. Specifically, at the "Processing" critical control point, the plan's critical limit for controlling pathogen growth, including *Clostridium botulinum*, was insufficient. FDA recommends that refrigerated roe packed in reduced oxygen packaging achieve a specific level of acidity (pH) as a secondary barrier to prevent *Clostridium botulinum* growth and toxin formation, in addition to refrigeration. Although the firm stated they were conducting a scientific study to validate their process, they had not provided the study for evaluation.

The FDA warned that failure to promptly correct this violation could lead to further action, including product seizure and injunction against the firm's operation. The letter also stated that FDA may assess fees for re-inspection-related costs due to the identified food safety noncompliance. Freshwater Fish Products, Inc. was required to respond in