FDA Inspection 695802 — Cepheid
The FDA completed an inspection of Cepheid on October 29, 2010 in Sunnyvale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 29, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sunnyvale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |