FDA Inspection 819002 — Amron International, Inc.
The FDA completed an inspection of Amron International, Inc. on February 19, 2013 in Vista, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |