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

This FDA Form 483 document details significant observations made during an inspection of Micro Medical Solutions, Inc., conducted from May 20 to May 23, 2025. The report, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, highlights two main areas requiring corrective action. First, the company's procedures for corrective and preventive actions (CAPAs) were deemed inadequate. Specifically, three out of seventeen CAPAs reviewed lacked verification or validation to ensure the effectiveness of implemented changes and to confirm they did not adversely affect the finished medical device. There was an absence of objective evidence demonstrating the efficacy of procedural updates over time. Second, the firm failed to properly identify the acceptance status of incoming product. Material designated for the MicroStent Peripheral Vascular Stent System, which had failed its initial acceptance inspection, was not appropriately labeled to indicate its nonconforming status. This directly violates the company's own "Material Handling and Inventory Control" procedure. Micro Medical Solutions, Inc. has committed to correcting both identified issues.