FDA 483 - Customed, Inc. - April 18, 2023

An FDA inspection of Customed, Inc. in Fajardo, PR, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately control non-conforming products, including not initiating field actions for known component issues, and conducted inadequate complaint investigations. Additionally, observations noted non-adherence to sterile manufacturing gowning procedures and a complete lack of internal audits and management reviews for the year 2022.