483
Micro Medical Solutions, Inc.Micro Medical Solutions, Inc. – FDA 483, May 23, 2025
Record Details
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.
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ID · c118ed5e-aa0c-40f0-a835-7d32cd4a6071
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