FDA Inspection 1115562 — Aesthetics Biomedical, Inc.
The FDA completed an inspection of Aesthetics Biomedical, Inc. on Jan 21, 2020 in Phoenix, AZ. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 21, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |