FDA Inspection 1097398 — American Contract Systems
The FDA completed an inspection of American Contract Systems on Jul 25, 2019 in Zelienople, PA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 25, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zelienople, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |