FDA Inspection 646620 — Acuderm, Inc.
The FDA completed an inspection of Acuderm, Inc. on February 19, 2010 in Ft Lauderdale, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ft Lauderdale, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |
| 3283 | 21 CFR 820.90(a) | Specific non-conforming product procedures |
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 3428 | 21 CFR 820.50(a)(3) | Acceptable supplier records |
| 537 | 21 CFR 820.70(a) | Production processes |