988458
Transdermal Cap Inc. — FEI 3008699663
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 22, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Highland Heights, OH (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3841 | 21 CFR 820.90(b)(2) | Product rework adverse effects {see also 820.184} |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |