# FDA 483 - Auxilium Medical Inc. - March 26, 2025

Source: https://www.keypedia.com/records/483/auxilium-medical-inc/33883a9f-e6df-420e-bd18-81f50441e3be

> FDA 483 for Auxilium Medical Inc. on March 26, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Auxilium Medical Inc.
- Inspection Date: 2025-03-26
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Auxilium Medical Inc. in Charleston, SC, a manufacturer of Class II medical devices, was inspected by the FDA from March 24-26, 2025. The inspection revealed significant deficiencies across its quality system, particularly concerning design controls, device master records, purchasing controls, quality audits, management review, and device history records. These issues indicate a broad lack of established procedures and documentation for ensuring device quality and regulatory compliance.

## Related Officers

- [Gamal A. Norton](https://www.keypedia.com/people/gamal-a-norton/6b52c9e6-d579-4994-81ee-e734eb1f0a67)

Company: https://www.keypedia.com/companies/auxilium-medical-inc/bf464f94-8b8b-45cb-9b3c-65a576031125

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7