FDA WARNING_LETTER - Catalina Offshore Products, Inc - April 09, 2010

On June 14, 2010, the FDA issued a Warning Letter to Catalina Offshore Products following an inspection from April 5-9, 2010. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110).

The FDA found the firm's ready-to-eat raw sea urchin and tuna loin to be adulterated due to insanitary conditions. Specific violations included:

1. **Inadequate Sanitation Monitoring (21 CFR 123.11(b)):** The firm failed to sufficiently monitor water safety, food contact surface cleanliness, cross-contamination prevention, and maintenance of handwashing/toilet facilities. Evidence included hoses lacking backflow devices, chemical equipment connected without backflow devices, seafood residue on surfaces/equipment/clothing, employees touching insanitary surfaces then food, condensate dripping onto seafood, lack of screens/filters, floor cleaning overspray, and lack of soap/paper towels at sinks, and leaking restroom wastewater. The firm's response was deemed inadequate, lacking evidence of corrective actions.

2. **Inadequate Sanitation Control Records (21 CFR 123.11(c)):** The firm did not maintain adequate sanitation monitoring records for handwashing/toilet facilities for sea urchin processing, specifically lacking