FDA Inspection 1336052 — Paradigm Packaging West, LLC
The FDA completed an inspection of Paradigm Packaging West, LLC on Aug 13, 2026 in Rancho Cucamonga, CA. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 13, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rancho Cucamonga, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23139 | ISO 13485:2016 Clause 7.4.1 | Criteria for the evaluation and selection of suppliers not established |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23236 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not identified and controlled |
| 23249 | ISO 13485:2016 Clause 8.4 | Procedures for analysis of data not documented |
| 23250 | ISO 13485:2016 Clause 8.4 | Procedures for data analysis do not include determination of appropriate methods |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |