FDA WARNING_LETTER - Noxubee County Producers Inc. (dba Superior Fish Products) - December 16, 2009

The FDA issued a Warning Letter to Noxubee County Producers, Inc. following an inspection of their seafood processing facility in December 2009. The inspection 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), rendering their catfish products adulterated. Key deficiencies in the HACCP plan for raw catfish included inadequate monitoring procedures for aquaculture chemicals/drugs at receiving, insufficient verification procedures for chemical contaminants, and inappropriate corrective actions that failed to ensure the cause of deviations was corrected. The firm also failed to implement its record-keeping system by not obtaining required grower certificates and did not document corrective actions for sanitation failures or thermometer calibrations. Furthermore, the HACCP plan for lemon pepper marinade catfish lacked necessary CCPs for aquaculture drugs/chemicals and metal inclusion, had inappropriate corrective actions for undeclared additives, and inadequate allergen control verification. A significant labeling violation involved having two conflicting ingredient statements on the product. The company must provide a written response within 15 working days detailing specific corrective actions, including revised HACCP plans and verification records, to avoid potential product seizure or injunction.