FDA WARNING_LETTER - Carolina Seafood Company Inc - May 02, 2025

The FDA issued a Warning Letter to Carolina Seafood Inc. following an inspection from April 29 to May 2, 2025, at their McClellanville, SC facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically concerning their ready-to-eat (RTE) crab dip and shrimp dip products. These products are deemed adulterated under the Federal Food, Drug, and Cosmetic Act because they were prepared, packed, or held under conditions that could render them injurious to health.

Key violations for the crab dip HACCP plan included failing to identify metal inclusion and undeclared allergens as potential food safety hazards. Critical limits for controlling *Clostridium botulinum* growth during product receipt were inadequate, lacking specific temperature and icing parameters. Monitoring procedures for processing time and temperature, and for ice presence, were also insufficient. Additionally, the firm"s proposed corrective actions for various critical control points were inappropriate, often failing to include discontinuation of problematic suppliers or destruction/diversion of affected product.

For the shrimp dip HACCP plan, critical limits for pathogen reduction, such as *Listeria monocytogenes*, and cumulative unrefrigerated processing times were inadequate. This plan also failed to identify metal inclusion as a reasonably likely hazard. Furthermore, corrective actions for all critical control points were deemed insufficient as they did not address the root cause of deviations.

Carolina Seafood Inc. must respond in writing within fifteen working days, detailing specific corrective steps, including supporting documentation, to address these violations and prevent recurrence. Failure to adequately resolve these issues could result in legal action, such as product seizure, injunctions, or suspension of the facility"s registration.