FDA 483 - Micro Medical Solutions, Inc. - May 23, 2025

Micro Medical Solutions, Inc. in Woburn, MA, was inspected by the FDA from May 20-23, 2025, and received a Form 483 with two observations. The inspection revealed deficiencies in the firm's corrective and preventive action procedures, specifically regarding the verification of CAPA effectiveness. Additionally, the firm failed to properly identify nonconforming incoming materials used for its MicroStent Peripheral Vascular Stent System.