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Talk to a SpecialistTalk to a SpecialistAllay Pharmaceuticals, LLC received a warning letter for significant current good manufacturing practice (CGMP) violations at its drug manufacturing facility in Hialeah, Florida, following an FDA inspection in May 2020. The company failed to establish adequate written procedures for production and process control, and its drug products—which contain protein components and are intended to treat disease—were found to be adulterated for not conforming to compendial standards for strength, quality, or purity. The violations rendered the firm's finished pharmaceutical products non-compliant with CGMP regulations under 21 CFR parts 210 and 211, making them adulterated under the Federal Food, Drug, and Cosmetic Act.