FDA Inspection 695885 — Sanjenics, Inc.
The FDA completed an inspection of Sanjenics, Inc. on Oct 7, 2010 in Nanto-shi. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 7, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nanto-shi (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |