FDA Inspection 1230398 — Amrex Zetron Inc
The FDA completed an inspection of Amrex Zetron Inc on February 8, 2024 in Paramount, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 8, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Paramount, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |