FDA 483 - Axcesor, Inc. - June 16, 2023

An FDA inspection of Axcesor Inc., a contract manufacturer in Menomonee Falls, WI, revealed significant deficiencies in their quality system. Observations included inadequate validation of their clean room used for packaging medical devices and failures in establishing and documenting corrective and preventive actions for complaints and non-conformances. These issues suggest a lack of robust controls over critical manufacturing processes and complaint handling.