FDA Inspection 695676 — Okamoto Industries Inc.
The FDA completed an inspection of Okamoto Industries Inc. on Oct 22, 2010 in Bunkyo. 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
- Oct 22, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Bunkyo (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |