FDA Inspection 1264972 — Auxilium Medical Inc.
The FDA completed an inspection of Auxilium Medical Inc. on Mar 26, 2025 in Charleston, SC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 26, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3155 | 21 CFR 820.181(a) | DMR device specifications |
| 3159 | 21 CFR 820.184 | DHR content |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |