FDA Inspection
CepheidCepheid – FDA Inspection, Oct 29, 2010
Record Details
This FDA Inspection record concerns Cepheid, with an inspection on October 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cepheid
- Inspection Date
- October 29, 2010
- Product Type
- Devices
View Company Profile
ID · c7096018-7f22-4e9e-837c-29fca4c4b4e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695802
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cepheid
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 16, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cepheid
- FDA Inspection 1026773 - 2017-08-09
- FDA Inspection 928802 - 2015-06-16
- FDA Inspection 763635 - 2012-01-13
- FDA Inspection 612704 - 2009-09-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.