FDA Inspection 1143298 — Alliance Precision Plastics Corporation
The FDA completed an inspection of Alliance Precision Plastics Corporation on June 4, 2021 in Rochester, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 4, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |