Intershell International Corp. – FDA Warning Letter, Aug 29, 2014

On September 26, 2014, the FDA issued a Warning Letter to Intershell International Corp. following an inspection from August 22-29, 2014. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their pasteurized canned crabmeat adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for pasteurized canned crabmeat failed to list "receiving" as a critical control point for controlling *Clostridium botulinum* toxin formation. Company-owned refrigerated trucks lacked continuous temperature monitoring, product was not covered in ice during transport, and internal product temperatures were not recorded at delivery. Transport records were not reviewed for temperature control history. The firm's September 9, 2014, response was inadequate as it lacked an amended HACCP plan, evidence of implemented corrective actions, or a timetable. 2. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan's critical limit at the (b)(4) critical control point was insufficient for controlling *Clostridium botulinum