FDA Inspection 562804 — BioSculptor Corporation
The FDA completed an inspection of BioSculptor Corporation on February 3, 2009 in Hialeah, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3689 | 21 CFR 820.100(a)(2) | Investigation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |