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Talk to a SpecialistTalk to a SpecialistFrontier Biologics, LLC was cited for manufacturing and distributing two unlicensed biological products—Purified Fluid Allograft derived from human amniotic fluid and Allograft Matrix derived from human amniotic membrane—without FDA approval, violating sections 505(a) of the FD&C Act and 351(a)(1) of the PHS Act. During an FDA inspection in February-March 2024, the company's manufacturing operations were found to have significant current good manufacturing practice (CGMP) violations under 21 CFR parts 210 and 211, rendering the products adulterated. The company was prohibited from introducing or delivering these products into interstate commerce without obtaining required FDA approvals.