FDA WARNING_LETTER - FFE Transportation Services, Inc - October 18, 2011

On December 6, 2011, the FDA issued a Warning Letter to FFE Transportation Services, Inc. following an inspection of their seafood processing facility in Lancaster, Texas, from October 12-18, 2011. The inspection revealed a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The primary violation identified was the firm's failure to have and implement a written HACCP plan for canned pasteurized crabmeat to control the food safety hazard of *C. botulinum*, as required by 21 CFR 123.6(a) and (b). This renders their canned pasteurized crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), meaning it was prepared, packed, or held under insanitary conditions that may render it injurious to health.

Additionally, the firm lacked an individual trained in seafood HACCP or otherwise qualified through job experience to perform seafood HACCP functions, violating 21 CFR 123.10.

While the Warehouse Manager verbally indicated corrective actions during the inspection closeout, no written documentation was provided. The FDA stated that failure to promptly correct these violations could lead to further action, including product seizure and/or injunction against the firm's operations. FFE Transportation Services, Inc. was required to