1067369
American Contract Systems — FEI 3011389083
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 2, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zelienople, PA (United States)
Citations
| ID | CFR | Description |
|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 537 | 21 CFR 820.70(a) | Production processes |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |