FDA WARNING_LETTER - Copper River Seafoods, Inc. - August 04, 2010

An FDA inspection of the food and seafood processing facility at 300 Cannery Row, Cordova, Alaska, on August 3-4, 2010, revealed serious violations of Low Acid Canned Food (LACF) (21 CFR Parts 108, 113), seafood Hazard Analysis and Critical Control Point (HACCP) (21 CFR Part 123), and Current Good Manufacturing Practice (CGMP) (21 CFR Part 110) regulations. These deficiencies render the firm's smoked salmon and other seafood products adulterated. Key violations included: 1) Failure to adequately monitor sanitation conditions and practices (21 CFR 123.11(b)), evidenced by residual food/dirt, dripping condensation, peeling paint, improper chemical storage, re-using dropped fish, and an exposed de-watering box. 2) Failure to file a thermal process for smoked salmon in foil pouches and notify FDA of LACF registration changes (21 CFR 108.35(c)(2)). 3) Failure to reprocess or evaluate product when critical factors, specifically fill weight, were out of control for low-acid foods (21 CFR 113.89). 4) Failure to conduct a hazard analysis and implement a written HACCP plan for smoked salmon strips to control Staphylococcus aureus toxin formation during drying (21 CFR 123.6(a) and (b)). The FDA requires a written response within fifteen working days detailing specific corrective actions, including documentation like LACF scheduled processes and HACCP plans. Failure to promptly correct these violations may result in further regulatory action, such as product seizure and injunctions against the firm's operations.