FDA Inspection 1167018 — American Contract Systems
The FDA completed an inspection of American Contract Systems on March 25, 2022 in Zelienople, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 25, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zelienople, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3219 | 21 CFR 820.70(d) | Training temp work under special environmental conditions |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |