1157207
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 19, 2021
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Vandalia, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |