FDA Inspection 1332800 — Westec Plastic Corporation
The FDA completed an inspection of Westec Plastic Corporation on Aug 24, 2026 in Livermore, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 24, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Livermore, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23085 | ISO 13485:2016 Clause 7.1 | Processes needed for product realization not planned and developed |
| 23140 | ISO 13485:2016 Clause 7.4.1 | Supplier evaluation and selection criteria do not include required elements |