FDA Inspection 827646 — Innova Vision Inc.
The FDA completed an inspection of Innova Vision Inc. on Mar 28, 2013 in Hsin-Chu. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hsin-Chu (Taiwan)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |