FDA EIR - Poiesis Medical, LLC - October 30, 2024

The FDA conducted inspections at two companies, Poiesis Medical, LLC, and Pathy Medical, LLC, revealing significant compliance issues.

Poiesis Medical, LLC, located in Jupiter, FL, was inspected from October 29-30, 2024. The company, a specification developer, failed to conduct management reviews of its quality system as required. Specifically, the firm did not document management reviews for 2022, 2023, or 2024, violating their internal procedure "Management Review, SOP-007, Version B." The FDA emphasized the necessity for the company to perform regular self-audits to ensure compliance with quality system requirements.

Pathy Medical, LLC, a medical device manufacturer in Eden Prairie, MN, was inspected from October 23 to November 19, 2024. The inspection revealed multiple issues: management failed to conduct regular reviews of the quality management system, with only one review documented since December 2020. Additionally, the firm inadequately established corrective and preventive action (CAPA) procedures, with several CAPAs initiated but not effectively implemented. The company also lacked proper procedures for monitoring and controlling process parameters for validated processes, specifically concerning the sterilization validation of their Light Jacket product.

Both companies are required to address these issues promptly to ensure compliance with FDA regulations and maintain the effectiveness of their quality management systems.