FDA Inspection 932436 — Omron Healthcare Co., Ltd.
The FDA completed an inspection of Omron Healthcare Co., Ltd. on May 29, 2015 in Muko. 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
- May 29, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Muko (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |