FDA Inspection 1040787 — Amrex Zetron Inc
The FDA completed an inspection of Amrex Zetron Inc on January 17, 2018 in Paramount, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 17, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Paramount, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |