FDA Inspection 550852 — CliniSys, Inc
The FDA completed an inspection of CliniSys, Inc on November 14, 2008 in Tucson, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Tucson, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3304 | 21 CFR 820.100(a)(5) | Changes to correct/prevent quality problems |
| 3398 | 21 CFR 820.80(d)(3) | No release signature |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |