FDA WARNING_LETTER - Grand Strand Sandwich Company, Inc. - February 27, 2020

The FDA inspected a ready-to-eat (RTE) sandwich facility in Longs, SC, from February 24-27, 2020, and found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Environmental samples revealed the presence of *Listeria monocytogenes* (L. monocytogenes), a human pathogen.

The facility's RTE sandwiches are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Failure to comply with preventive controls is also prohibited by section 301(uu) of the Act.

Key violations include: 1. **Inadequate Preventive Controls for Environmental Pathogens:** The firm failed to implement adequate sanitation controls to minimize *L. monocytogenes*, evidenced by a resident strain detected in 2017, 2018, and 2020 inspections. Whole genome sequencing confirmed a single strain, genetically identical to a 2015 clinical isolate. Previous corrective actions, including deep cleaning and third-party consultations, were ineffective. 2. **Failure to Identify Supply-Chain Hazards:** The firm did not identify pathogens (e.g., *L. monocytogenes*) in raw materials like deli salad and meats as hazards requiring supply