FDA 483 - Defender Safety, Inc - October 05, 2022

An FDA inspection of Defender Safety, Inc. in Plainview, NY, a repackager and design specification developer of Class II medical devices (PPEs), identified three significant observations. The firm failed to establish written agreements with suppliers for change notifications, particularly for medical grade masks. Additionally, procedures for acceptance activities were inadequate, lacking evidence of required testing for bacterial and particulate filtration efficiency, and no quality audits had been performed by the firm.