FDA 483 - Chara Biologics, Inc. - August 16, 2024

Chara Biologics, Inc. in Chatsworth, CA, a stem cell manufacturer, was inspected by the FDA from July 23 to August 16, 2024. The inspection revealed significant deficiencies across multiple areas, including lack of product traceability, inadequate donor eligibility determination, absence of written procedures for manufacturing and quality control, and improper handling of expiration dates and labeling. These issues indicate a severe lack of control over the identity, strength, purity, and quality of their drug products, particularly CharaCore, CharaExo, and CharaOmni.