FDA Inspection 612704 — Cepheid
The FDA completed an inspection of Cepheid on September 16, 2009 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
- September 16, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sunnyvale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3141 | 21 CFR 820.150(a) | Storage procedures to prevent mix-ups |
| 3142 | 21 CFR 820.150(a) | Storage procedures to avoid release of unsuitable product |
| 3144 | 21 CFR 820.160(a) | Control/distribution procedures |