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INCELL Corporation LLC manufactured an unapproved amniotic fluid-derived drug product without proper FDA licensure, violating sections 505(a) and 351(a)(1) of federal law. An FDA inspection between September 25-29, 2023 documented significant current good manufacturing practice (CGMP) violations under 21 CFR parts 210 and 211, rendering the product adulterated and misbranded, with the company prohibited from introducing it into interstate commerce. The violations included deficiencies in the company's manufacturing methods, facilities, and controls that failed to meet required standards for drug manufacturing, processing, packing, and holding.