FDA Inspection 617077 — Xintec Corp
The FDA completed an inspection of Xintec Corp on Sep 10, 2009 in Alameda, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 10, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alameda, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 4189 | 21 CFR 820.198(a) | General |