FDA Inspection 865535 — Mauna Kea Technologies
The FDA completed an inspection of Mauna Kea Technologies on Jan 30, 2014 in Paris. 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
- Jan 30, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Paris (France)
Citations
| ID | CFR | Description |
|---|---|---|
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3696 | 21 CFR 820.100(b) | Documentation |