FDA WARNING_LETTER - La Milagrosa 1 LLC - October 23, 2024

The FDA inspected a human food manufacturing facility in Passaic, NJ, from September 17 to October 23, 2024, focusing on ready-to-eat (RTE) Latin style cheese products. 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), leading to the determination that the RTE cheese products are adulterated.

Key violations include the failure to prepare and implement a comprehensive food safety plan, overseen by a preventive controls qualified individual (PCQI), lacking essential elements such as a written hazard analysis, preventive controls, supply-chain program, recall plan, monitoring procedures, corrective action procedures, and verification procedures. Specifically, the facility did not identify and evaluate undeclared allergens (milk) or the growth of bacterial pathogens (e.g., *Listeria monocytogenes*) as hazards requiring preventive controls. Inadequate process controls were noted, including uncalibrated pasteurizer thermometers and no written procedure for recording cooler temperatures for cheese storage. The facility also failed to identify and evaluate contamination with environmental pathogens, with inadequate sanitation controls observed, such as improper sanitizing solution preparation and employees handling RTE cheese with bare hands after touching other surfaces, a repeat deviation from a June 2023 inspection.

Further CGMP violations included inadequate floor drainage in RTE cheese processing rooms, leading to pooled water with cheese residue (a repeat deviation),