FDA Inspection 1116117 — Paradigm Packaging West, LLC
The FDA completed an inspection of Paradigm Packaging West, LLC on January 28, 2020 in Rancho Cucamonga, CA. 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
- January 28, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |