FDA Inspection 1042771 — Commercial Plastics Kenosha LLC
The FDA completed an inspection of Commercial Plastics Kenosha LLC on Feb 28, 2018 in Kenosha, WI. 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 28, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Kenosha, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 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 |