FDA Inspection 1067369 — American Contract Systems
The FDA completed an inspection of American Contract Systems on Oct 2, 2018 in Zelienople, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 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 |