FDA Inspection 986659 — YA-MAN LTD.
The FDA completed an inspection of YA-MAN LTD. on Aug 18, 2016 in Koto. 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
- Aug 18, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Koto (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |