# Auxilium Pharmaceuticals, Inc. – FDA 483, Jun 5, 2026

Source: https://www.keypedia.com/records/483/auxilium-pharmaceuticals-inc/0b51207f-94ec-4b5e-9f58-006989f35c1c

> FDA 483 for Auxilium Pharmaceuticals, Inc. on June 05, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Auxilium Pharmaceuticals, Inc.
- Inspection Date: 2026-06-05
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Endo USA, Inc. in Horsham, PA, an API manufacturer, revealed significant deficiencies in laboratory controls and quality unit procedures. The firm's validated test method for an API impurity assay was found to be scientifically unsound and unreliable, with a low success rate despite previous corrective actions. Additionally, the Quality Unit failed to consistently follow established procedures for validation maintenance, cleaning validations, and stability testing, indicating a systemic breakdown in quality assurance.

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.keypedia.com/companies/auxilium-pharmaceuticals-inc/4c7c1ecf-f1d3-49f9-af76-cf9e9de32fa6

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8