# FDA 483 - EnduroMed - June 17, 2025

Source: https://www.globalkeysolutions.net/records/483/enduromed/c7b46f03-a50f-4b47-a465-ec2fd334c168

> FDA 483 for EnduroMed on June 17, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EnduroMed
- Inspection Date: 2025-06-17
- Product Type: biologics
- Office Name: Minneapolis District Office
- Summary: EnduroMed, an HCT/P establishment in Brookfield, WI, was inspected by the FDA from June 16-17, 2025. The inspection revealed a significant issue regarding the firm's failure to approve core Current Good Tissue Practice (CGTP) procedures by a responsible person before their implementation. This indicates a fundamental lapse in quality system controls.

## Related Officers

- [Charles D. Boison](https://www.globalkeysolutions.net/people/charles-d-boison/b128f4a3-c1b1-409f-9291-27deb111d1e5)

Company: https://www.globalkeysolutions.net/companies/enduromed/2d54a35a-1db7-4f5f-8ce4-91d855d4956c

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