FDA 483 - Unifirst-First Aid Corporation - May 24, 2018

Unifirst First Aid Corp, a repackager/relabeler in Earth City, MO, was cited for two significant issues during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically by not including regulatory observations in their CAPA system. Additionally, procedures for receiving and evaluating complaints were inadequate, leading to customer injury complaints not being properly assessed for Medical Device Reporting requirements.