OFP Ingredients LLC – FDA Warning Letter, Jul 23, 2021

The FDA issued a Warning Letter to a dry milk powder processing facility following an inspection from May to July 2021, which revealed serious violations of the CGMP & PC rule (21 CFR Part 117). Environmental samples confirmed the presence of *Salmonella Cubana*, a human pathogen, indicating adulterated ready-to-eat (RTE) dry milk powder.

Key violations include: 1. **Inadequate Preventive Controls:** The facility failed to implement effective sanitation preventive controls for environmental pathogens like *Salmonella*, despite identifying them as a hazard. Whole genome sequencing showed the same *Salmonella* strain present since 2009, indicating a resident pathogen. Corrective actions for previous *Salmonella* findings were insufficient. 2. **Deficient Supply-Chain Program:** The facility did not adequately verify suppliers for hazards like *Salmonella* in lecithin. An audit certificate reviewed for a supplier covered the wrong location, and the correct certificate was outdated. Required testing for new suppliers was not conducted. 3. **Poor Manufacturing Conditions:** Leaking production equipment was observed, leading to water and liquid accumulation, and potential microbial growth. Forklifts used in non-production areas were found to spread *Salmonella* to production areas. 4. **Inadequate Hygienic Practices:** Employees handling equipment and product after cleaning were not wearing fresh uniforms.

The FDA requires a written response within 15 working days detailing corrective actions, recurrence prevention,