FDA WARNING_LETTER - Chara Biologics, Inc. - August 16, 2024

The FDA inspected Chara Biologics, Inc. from July 23 to August 16, 2024, regarding its human amniotic fluid product, CharaExo, and umbilical cord-derived products, CharaCore and CharaOmni. The FDA determined these products are unapproved new drugs and unlicensed biological products, violating sections 505(a) of the FD&C Act and 351(a)(1) of the PHS Act.

The products are marketed for various diseases and conditions, including autoimmune disorders, neurodegenerative conditions, diabetes, and cardiovascular diseases, indicating their intended use as drugs and biological products. CharaCore and CharaOmni are also classified as HCT/Ps but fail to meet minimal manipulation and homologous use criteria under 21 CFR 1271.10(a), thus not being regulated solely under section 361 of the PHS Act.

Significant CGMP and CGTP violations were identified, including failure to establish an adequate quality unit (21 CFR 211.22(a), (d)) with responsibilities for approving/rejecting products, ensuring laboratory controls, written production procedures, record review, complaint handling, and label control. Additionally, the firm failed to maintain donor-eligibility documentation for umbilical cord donors (21 CFR 1271.55(d)(1)(iii)). CharaExo