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

Source: https://www.keypedia.com/records/483/pathy-medical-llc/db614f8e-1ca9-4ad3-b8ab-29ab34fccbcb

> FDA 483 for Pathy Medical, LLC on November 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pathy Medical, LLC
- Inspection Date: 2024-11-19
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: 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.

## Related Officers

- [Benjamin W. Anderson](https://www.keypedia.com/people/benjamin-w-anderson/a3c0961c-6a83-4bd7-abb8-02c5c8dd3a35)

Company: https://www.keypedia.com/companies/pathy-medical-llc/b4bc8fcb-5631-4477-90fd-7b69223b1e5c

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d