FDA Inspection 695735 — Mani, Inc. - Kiyohara Facility
The FDA completed an inspection of Mani, Inc. - Kiyohara Facility on Oct 7, 2010 in Utsunomiya. 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). 5 citations were 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
- Utsunomiya (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 3837 | 21 CFR 820.25(b) | Training records |