FDA 483 - Directmed, Inc - May 15, 2025

Directmed, Inc., a medical device manufacturer in Glen Cove, NY, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately document complaint investigations, specifically regarding follow-up on potential adverse events and responses to complainants. Additionally, the inspection revealed inadequate documentation of corrective and preventive action activities, including the absence of separate CAPA files and proper verification of effectiveness.