FDA Inspection 798286 — Mizuho OSI
The FDA completed an inspection of Mizuho OSI on Sep 11, 2012 in Union City, CA. 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 11, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Union City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 733 | 21 CFR 803.50(b)(1) | Reporting Information Reasonably Known |