FDA Inspection 1253941 — Commercial Plastics Kenosha LLC
The FDA completed an inspection of Commercial Plastics Kenosha LLC on Nov 7, 2024 in Kenosha, WI. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 7, 2024
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Kenosha, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |