FDA Inspection 796660 — Osachi Co Ltd
The FDA completed an inspection of Osachi Co Ltd on August 9, 2012 in Okaya. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 9, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Okaya (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |