FDA 483 - Activbody, Inc. - August 22, 2025

Activbody, Inc. in San Diego, CA, a manufacturer of Class II medical devices, was cited for five significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for design validation, complaint handling, training, and management review. Additionally, Activbody did not register the Unique Device Identifier (UDI) for a Class II medical device in the FDA's GUDID database.