FDA WARNING_LETTER - Iacofano's Group LLC - January 22, 2020

The FDA inspected Iacofano's Catering & Foodservice in Charleston, SC, from January 7-22, 2020, finding serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). The facility's food is deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: - **Incomplete Food Safety Plan:** Failure to conduct a comprehensive hazard analysis for RTE foods, specifically omitting food allergens (e.g., cross-contact on shared equipment) and environmental pathogens (e.g., *Listeria monocytogenes*, *Salmonella*) as hazards requiring preventive controls. - **Lack of Preventive Controls:** Absence of adequate food allergen controls, despite manufacturing products with different allergen profiles. - **Undocumented Monitoring:** No records of monitoring preventive controls were available. - **Unimplemented Environmental Monitoring:** Failure to fully implement environmental monitoring procedures for pathogens, with limited testing compared to the established program. - **Poor Hygienic Practices:** Employees observed handling insanitary objects and food with torn gloves, and cross-contaminating allergens without changing gloves. - **Facility Disrepair and Filth:** Rusty, sagging, discolored ceilings; filthy ceiling vents; loose floor tiles; deeply pitted floor thresholds; residue on clean utensil shelves