FDA WARNING_LETTER - Eagle Smoked Salmon, Inc. - July 17, 2017

The FDA conducted an inspection of Eagle Smoked Salmon, Inc. in Gypsum, Colorado, on July 13 and 17, 2017, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's vacuum packed cold smoked salmon, hot smoked salmon, and Smoked Salmon Spread were deemed adulterated. Key violations included the absence of a HACCP plan for Smoked Salmon Spread to control pathogen growth and undeclared allergens. The HACCP plan for Cold Smoked Salmon Vacuum Packed lacked critical control points for raw salmon receiving and metal inclusion, with inadequate critical limits and monitoring procedures for pathogen control. Furthermore, monitoring procedures and frequencies at the storage CCP for Clostridium botulinum in cold smoked salmon were insufficient. The firm failed to implement monitoring procedures as listed in its HACCP plans for both hot and cold smoked salmon products, and its corrective action plans were deemed inappropriate, not ensuring the cause of deviations was corrected or product safety. Finally, HACCP plans lacked ongoing verification activities, including calibration of monitoring instruments, and no calibration records were available. The FDA requires prompt corrective actions, a written response within 15 working days detailing specific steps and prevention plans, and warns of potential regulatory enforcement, including seizure or injunction, and re-inspection fees if compliance is not achieved.