FDA Inspection 810991 — PhotoMedex, Inc.
The FDA completed an inspection of PhotoMedex, Inc. on Nov 27, 2012 in Horsham, PA. 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
- Nov 27, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Horsham, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |