FDA 483 - Customed, Inc. - October 04, 2024

Customed, Inc., a manufacturer of Class 2 medical devices in Fajardo, PR, was cited for significant quality system deficiencies. The inspection revealed failures in controlling non-conforming products, including manufacturing in out-of-spec temperatures and using expired sterile barrier components. Additionally, the firm did not adequately implement its corrective and preventive action procedures, nor did it properly handle product storage conditions for critical components.