CosmoFrance, Inc. – FDA 483, Sep 16, 2021

An FDA inspection of CosmoFrance, Inc., a relabeler/repackager of medical devices in Miami, FL, revealed significant deficiencies in their quality management system. Observations included inadequate control over document changes, failure to properly document corrective and preventive actions, and a lack of documentation for incoming product acceptance. These issues indicate a need for comprehensive improvements in their operational procedures and record-keeping practices.