Ramar International Corporation – FDA Warning Letter, Jun 5, 2020

The FDA inspected an RTE ice cream facility from May 20 to June 5, 2020, following a voluntary recall due to *Listeria monocytogenes* (L. mono) in product. The inspection revealed serious violations of the CGMP & PC rule (21 CFR Part 117), and environmental swabs confirmed L. mono presence, rendering the ice cream adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: - **Hazard Analysis Deficiencies:** Failure to identify environmental pathogens as a hazard requiring preventive controls for RTE ice cream exposed to the environment post-pasteurization (21 CFR § 117.130(a)(1), (c)(1)(ii)). - **Sanitation Control Failures:** Recurring *Listeria spp.* findings in the facility, including L. mono genetically identical to a clinical isolate, indicating inadequate corrective actions. Specific issues included L. mono on a freezer door, broom bristles, and a cart used for transporting ingredients, demonstrating ineffective sanitation procedures (21 CFR § 117.80(c)(2)). - **General GMP Violations:** - Contamination risk from dripping liquids onto exposed product containers and ingredients (21 CFR § 117.80(c)(2)). - Unsanitary grounds with standing water and gravel in material transport paths (2