795561
Psoria Shield, Inc. — FEI 3008872264
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Utica, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 14730 | 21 CFR 860.7(g)(2) | Rpts of safety & effectiveness, adulteration or misbranding |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5700 | 21 CFR 1002.10 | Failure to submit, distinct marking |
| 5812 | 21 CFR 1002.30(a)(2) | Results of tests |
| 636 | 21 CFR 803.17(b)(2) | Reports and information documentation |