Loading…
Celularity, Inc. was cited for manufacturing and distributing Interfyl®, a decellularized human placental connective tissue matrix product, as an unapproved new drug and unlicensed biological product in violation of sections 505(a) of the FD&C Act and 351(a)(1) of the PHS Act. The company failed to obtain either an approved New Drug Application or a Biologics License Application before introducing the product into interstate commerce. The FDA identified these violations during a facility inspection conducted in August 2023 and through review of the company's website and distributor marketing materials.