1024308
Ad-Tech Medical Instrument Corporation — FEI 2183456
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- September 5, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Oak Creek, WI (United States)
Citations
| ID | CFR | Description |
|---|
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |