FDA Inspection 849855 — Strata Skin Sciences, Inc.
The FDA completed an inspection of Strata Skin Sciences, Inc. on Sep 24, 2013 in Carlsbad, CA. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: 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 |