849855
Strata Skin Sciences, Inc. — FEI 3002942014
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carlsbad, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3286 | 21 CFR 820.90(b)(1) | Procedures for product review,disposition lack of/inadequate |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |