FDA Inspection 544331 — Amrex Zetron Inc
The FDA completed an inspection of Amrex Zetron Inc on November 3, 2008 in Paramount, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 3, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Paramount, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3346 | 21 CFR 820.200(b) | Analyzing service report |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |
| 4058 | 21 CFR 820.20 | Management responsibility |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |