Cemco International Corp – FDA Warning Letter, Mar 24, 2015

On May 1, 2015, the FDA issued a Warning Letter to Cemco International Corp following an inspection of their Ft. Lauderdale, FL seafood processing facility from March 18-24, 2015. 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 (21 CFR Part 110).

Specifically, the firm's canned pasteurized crabmeat was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Key violations included:

1. **Inadequate Critical Limits:** The HACCP plan for pasteurized canned crabmeat listed an inadequate critical limit at the receiving critical control point ("to be receved [sic] at 40 F and transit time less than 4 hours") to control *C. Botulinum* toxin and pathogen growth (21 CFR 123.6(c)(3)).

2. **Inadequate Monitoring Procedures/Frequency:** The HACCP plan's monitoring procedure/frequency at the receiving critical control point ("thempurature [sic] of truck at delivery with date and time" with "thermometer, calibrated. If transport more than 4 hours temp. Monitoring device must be included" for "each lot") was insufficient to control *