FDA 483 - TAS Medical, Inc - August 15, 2025

TAS Medical, Inc. underwent an FDA inspection from August 13-15, 2025, at its Windermere, FL facility, which operates as a Specification Developer. The inspection resulted in a Form FDA 483, identifying an observation related to the firm's quality system. The primary issue noted was the inadequate establishment of procedures to ensure that all purchased products and services conform to specified requirements. Specifically, the company's internal procedure, "Purchasing and Supplier Controls" (Document No: TM-SOP-8 Rev: B), mandates purchasing from suppliers listed on an Approved Supplier List (ASL). However, investigators observed that TAS Medical, Inc. procured products from a supplier not included on their ASL. This observation indicates a deviation from their own documented quality management system, impacting the control of incoming materials and services essential for product quality and safety. While this FDA 483 report is not a final determination of compliance, it highlights a condition that requires attention. TAS Medical, Inc. is responsible for promptly addressing this observation by evaluating the deviation, implementing appropriate corrective actions to ensure adherence to their purchasing controls, and conducting internal self-audits to maintain overall quality system compliance.