FDA Inspection
CepheidCepheid – FDA Inspection, Jun 16, 2015
Record Details
This FDA Inspection record concerns Cepheid, with an inspection on June 16, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cepheid
- Inspection Date
- June 16, 2015
- Product Type
- Devices
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ID · da35e071-bda6-4198-8e8a-7f2abbcf740c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928802
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
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 |
| January 13, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2010 | 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 763635 - 2012-01-13
- FDA Inspection 695802 - 2010-10-29
- FDA Inspection 612704 - 2009-09-16
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