FDA WARNING_LETTER - Greenwood Ice Cream, LLC - June 25, 2021

The FDA issued a Warning Letter to a ready-to-eat (RTE) ice cream manufacturing facility in Chamblee, GA, following an inspection from June 22-25, 2021. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117).

Key violations include: 1. **Adulterated Products:** Ice cream products were deemed adulterated under 21 U.S.C. § 342(a)(4) due to insanitary conditions. Environmental samples tested positive for *Listeria monocytogenes* (L. mono), including a resident strain identified since 2016 through Whole Genome Sequencing (WGS), indicating inadequate sanitation controls. 2. **Inadequate Preventive Controls:** The facility failed to identify and implement adequate preventive controls for environmental pathogens (L. mono), undeclared allergens (soy in "Jersey Cookie Monster Ice Cream" leading to a Class II recall), and physical hazards like metal contamination. 3. **Insufficient Environmental Monitoring:** Written verification procedures for environmental monitoring were inadequate, with infrequent sampling and incomplete corrective action plans for positive results. 4. **Hazard Analysis Deficiencies:** The hazard analysis did not properly evaluate pathogens in raw materials (e.g., nuts, strawberries added post-pasteurization) or establish a supply-chain program.