FDA Inspection
Celera CorporationCelera Corporation – FDA Inspection, Jan 9, 2012
Record Details
This FDA Inspection record concerns Celera Corporation, with an inspection on January 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Celera Corporation
- Inspection Date
- January 9, 2012
- Product Type
- Devices
View Company Profile
ID · 7088d8f3-731f-45c4-b021-2dd067af382a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 761803
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.180Availability
- 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 Celera Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 24, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 5, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 12, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Celera Corporation
- FDA Inspection 904397 - 2014-11-24
- FDA Inspection 646608 - 2009-11-05
- FDA Inspection 596438 - 2009-06-12
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.