Crown O'Maine Organic Cooperative – FDA Warning Letter, Sep 8, 2011

On December 6, 2011, the FDA issued a Warning Letter to Crown O'Maine Organic Cooperative following an inspection from August 10 to September 8, 2011. 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 that the company's smoked salmon, smoked mussels, smoked haddock, and smoked shrimp were adulterated because they were prepared, packed, or held under insanitary conditions. Specific HACCP violations included the lack of written HACCP plans for these products to control pathogen growth and undeclared allergens, as required by 21 CFR 123.6(a) and (b). Additionally, the firm failed to maintain sanitation monitoring records for various critical areas, violating 21 CFR 123.11(c).

cGMP violations were extensive, including failure to exclude pests (21 CFR 110.35(c)), with laboratory analyses confirming rodent and insect filth in and around food products like oat groats and rye flour. Observations included rodent gnaw marks, excreta pellets, and live/dead insects in stored food and mill waste. The company voluntarily destroyed contaminated products. Further cGMP deficiencies included unsuitable building design facilitating pest entry (e.g., a