FDA WARNING_LETTER - Caito Fisheries, Inc. - February 26, 2014

An FDA inspection of Caito Fisheries, Inc. in Fort Bragg, CA, conducted from February 24-26, 2014, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's Dungeness crab products are considered adulterated. Key deficiencies included the failure to conduct a proper hazard analysis and list all necessary critical control points, such as receiving for pathogen growth in cooked crab from their San Francisco location, in their HACCP plan (21 CFR 123.6(a) and (c)(2)). The firm also failed to establish adequate critical limits in their HACCP plan for controlling Clostridium botulinum at the finished product labeling and for vacuum-packaged crab storage (21 CFR 123.6(c)(3)). Additionally, Caito Fisheries did not implement the monitoring procedures and frequencies listed in their HACCP plan for cooler storage (21 CFR 123.6(b) and (c)(4)), nor did they maintain required sanitation control records for water safety and employee health conditions for specified periods (21 CFR 123.11(c)). The firm's March 17, 2014, response to the Form FDA 483 was largely deemed inadequate by the FDA. The company must promptly correct these violations and respond within fifteen working days with detailed corrective actions and supporting documentation. Failure to comply may result in product seizure, injunction, and re-inspection fees.