FDA Inspection 750677 — Omron Healthcare Co., Ltd
The FDA completed an inspection of Omron Healthcare Co., Ltd on Oct 6, 2011 in Matsusaka. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 6, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Matsusaka (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |