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La Milagrosa 1 LLC, a ready-to-eat Latin cheese product manufacturer in Passaic, NJ, was cited for serious violations of Current Good Manufacturing Practice (CGMP) and Risk-Based Preventive Controls regulations under 21 CFR Part 117 during an FDA inspection from September through October 2024. The FDA determined that the company's cheese products were adulterated because they were prepared, packed, or held under insanitary conditions that could have resulted in contamination with filth or rendered them injurious to health. The violations included failures to comply with preventive controls provisions required under the CGMP & PC rule, which constitute a prohibited violation under section 301(uu) of the Federal Food, Drug, and Cosmetic Act. Although the company submitted corrective actions in response to the initial inspection observations, the FDA issued this warning letter to advise of continuing concerns regarding the facility's compliance failures.