FDA WARNING_LETTER - Ice Cream House LLC - March 26, 2024

The FDA conducted a follow-up inspection of an RTE ice cream manufacturing facility from February 21 to March 26, 2024, prompted by a July 2023 multistate Listeria monocytogenes outbreak linked to the firm's products, which resulted in hospitalizations and a product recall. The inspection 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 confirmed the presence of a resident L. monocytogenes strain in the RTE processing area, leading to a determination that the firm's products are adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Key violations include the failure to implement adequate preventive controls (21 CFR 117.135(a)(1)) for environmental pathogens, incomplete implementation of the allergen control program, a deficient supply-chain program (21 CFR 117.410(c)) lacking proper supplier verification, and poor CGMP maintenance (21 CFR 117.35(a)) evidenced by persistent leaks. The firm provided a response outlining corrective actions, which FDA will verify during a subsequent inspection. The company must respond within 15 working days detailing corrective steps to avoid potential legal action.