FDA WARNING_LETTER - Meyer Food Service LLC - October 07, 2009

On October 1-7, 2009, an FDA inspection of Meyer Food Service LLC dba Empire Fish Co. in Wauwatosa, WI, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render the firm's vacuum-packed cold-smoked salmon, bonito, mahi-mahi, tuna, wahoo, mackerel, jobfish, jack or crevalle, trevally, escolar, clams, cockles, mussels, oysters, scallops, and air-packed, hot-smoked salmon adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. Failure to conduct a hazard analysis and implement a written HACCP plan for vacuum-packed cold-smoked salmon to control *Clostridium botulinum* growth and toxin formation, violating 21 CFR 123.6(a) and (b). 2. Inadequate monitoring frequencies in HACCP plans for clams, cockles, mussels, oysters, scallops, and air-packed, hot-smoked fish at the "Refrigerate" critical control point. The listed monitoring frequency for cooler temperature was insufficient to control pathogen growth and toxin formation, as it did not provide adequate time/temperature data to detect deviations from the critical limit of (b)(4)°F or less, violating