FDA Inspection 661263 — Mizuho OSI
The FDA completed an inspection of Mizuho OSI on Jun 2, 2010 in Union City, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 2, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Union City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3696 | 21 CFR 820.100(b) | Documentation |