FDA Inspection 1205766 — WISE PLASTICS TECHNOLOGIES INC
The FDA completed an inspection of WISE PLASTICS TECHNOLOGIES INC on May 19, 2023 in West Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- West Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |