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AACE Pharmaceuticals received a warning letter for distributing adulterated ophthalmic drugs, including Lubricant PM Ointment, manufactured by their contract manufacturer Brassica Pharma Private Limited in violation of Current Good Manufacturing Practice (CGMP) regulations. FDA inspections of Brassica revealed critical manufacturing defects including poor aseptic practices for sterile drug production, fabricated microbiology records, microbial contamination in ISO 5 manufacturing areas, inadequate media fill and airflow studies, and use of ripped and visibly dirty gowning in aseptic processing areas. AACE's receipt and introduction of these adulterated products into interstate commerce violated the Federal Food, Drug, and Cosmetic Act, making the company responsible for distributing drugs manufactured under substandard conditions.