1193281
Swiss American CDMO, LLC — FEI 3001451826
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- December 19, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |