Auxilium Medical Inc *
Form 483 issued March 26, 2025 · Charleston, South Carolina
- Inspection
- Mar 24 – Mar 26, 2025
- Investigator
- Gamal A. Norton
- Observations
- 12
- Pages
- 8
- FEI number
- 3014650138
In short: On March 26, 2025, FDA issued a Form 483 with 12 observations to Auxilium Medical Inc * in Charleston, South Carolina (FEI 3014650138) after an inspection that ran Mar 24 – Mar 26, 2025. The investigator was Gamal A. Norton. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and design controls account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Design plans that describe or reference the design and development activities and define responsibility for implementation…
- 02
Design validation did not ensure the device conforms to defined user…
- 03
The device master record does not include or refer to the location…
- 04
There is no agreement with suppliers and contractors to notify you of changes in…
This inspection in context
Gamal A. Norton
16 documents · 2003–2025
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in North Carolina.
The firmAuxilium Medical Inc * history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Auxilium Medical Inc *?
FDA listed 12 observations on this Form 483, mostly about production & process controls, design controls and records & documents. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Auxilium Medical Inc *?
Gamal A. Norton is named on this Form 483, for the inspection of Mar 24 – Mar 26, 2025. Each investigator has a profile showing what they cite most.
When was Auxilium Medical Inc * inspected by FDA?
The inspection ran Mar 24 – Mar 26, 2025, and the Form 483 is dated March 26, 2025.
How do I get the full Form 483 for Auxilium Medical Inc *?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.