Pathy Medical, LLCNovember 19, 2024

FDA 483 - Pathy Medical, LLC - November 19, 2024

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Record Details

An FDA inspection of Pathy Medical, LLC, a medical device manufacturer in Eden Prairie, MN, revealed significant deficiencies in their quality management system. Observations included a lack of regular management reviews of the quality system, inadequate establishment and implementation of corrective and preventive actions, and insufficient monitoring and control procedures for a validated sterilization process.

Company: Pathy Medical, LLC
Inspection Date: November 19, 2024
Product Type: Device
Office: Minneapolis District Office
Person: Benjamin W. Anderson

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ID · db614f8e-1ca9-4ad3-b8ab-29ab34fccbcb