FDA WARNING_LETTER - Ocean Fresh LLC - September 09, 2010

An FDA inspection of Ocean Fresh, LLC's seafood processing facility in Fort Bragg, California, conducted from August 31 to September 9, 2010, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). These violations render the firm's ready-to-eat, raw sea urchin roe adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Significant deficiencies included a failure to consistently implement HACCP record-keeping (21 CFR 123.6(b) and (c)(7)) and monitoring procedures/frequency (21 CFR 123.6(b) and (c)(4)). The firm's corrective action plans were deemed inappropriate (21 CFR 123.7(b)), lacking provisions to prevent adulterated product from entering commerce. Furthermore, Ocean Fresh failed to maintain required sanitation control records (21 CFR 123.11(c)) and did not monitor sanitation conditions with sufficient frequency (21 CFR 123.11(b)), evidenced by issues with water safety, unclean food contact surfaces, and cross-contamination. Finally, the firm's HACCP plan lacked a critical control point for "Processing" to control pathogens (21 CFR 123.6(a) and (c)(2)). The FDA requires a written response within fifteen working days outlining specific corrections and supporting documentation, warning of potential product seizure or injunction if violations are not promptly addressed.