FDA Inspection 925884 — Aizu Olympus Co., Ltd.
The FDA completed an inspection of Aizu Olympus Co., Ltd. on Apr 17, 2015 in Aizuwakamatsu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 17, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Aizuwakamatsu (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3696 | 21 CFR 820.100(b) | Documentation |