Custom Assemblies, Inc. – FDA 483, Oct 6, 2022

Custom Assemblies, Inc. in Pine Level, NC, a manufacturer of Class II medical devices, was cited for significant deficiencies in its document control procedures and record-keeping practices. The inspection revealed issues such as missing approval forms, outdated documents, incomplete logs, and blank data sections in critical quality system records. These findings indicate a lack of adherence to the firm's own established procedures for maintaining records.