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Skye Biologics Holdings LLC manufactured unapproved placental connective tissue matrix allograft products (BioECM™) derived from umbilical cord that violated the Federal Food, Drug, and Cosmetic Act by operating as unlicensed biological products without required drug approval. The company's manufacturing operations deviated from current good manufacturing practice (CGMP) requirements under 21 CFR parts 210 and 211, rendering the products adulterated. The FDA inspection conducted in late 2022 identified significant violations of manufacturing standards, methods, facilities, and controls that made the introduction or delivery of these products into interstate commerce prohibited.