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Chara Biologics, Inc. was warned for manufacturing and distributing three unapproved biological products—CharaExo (human amniotic fluid) and CharaCore and CharaOmni (cellular products derived from human umbilical cord)—without a biologics license application (BLA) approval or new drug application (NDA), in violation of the Public Health Service Act and Federal Food, Drug, and Cosmetic Act. An FDA inspection conducted between July 23 and August 16, 2024, identified significant violations of current good manufacturing practice (CGMP) and current good tissue practice (CGTP) requirements under 21 CFR parts 210 and 211. The company's introduction and distribution of these unlicensed products into interstate commerce was prohibited under federal law.