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Talk to a SpecialistTalk to a SpecialistALI Pharmaceutical Manufacturing, LLC received a warning letter for manufacturing adulterated active pharmaceutical ingredients (APIs), specifically porcine thyroid products, due to significant deviations from current good manufacturing practice (CGMP). The FDA identified critical failures in process validation, including inadequate validation of porcine thyroid API manufacturing processes and intermediates that were not representative of current manufacturing conditions, lacked proper documentation of material specifications and equipment details, and relied on insufficient data to address potential process variations. The inspection, conducted in September-October 2022, found that the company's methods, facilities, and controls did not conform to CGMP standards required under the Federal Food, Drug, and Cosmetic Act.