Company
United StatesCelera Corporation, Walnut Creek, CA – FDA Inspections
Inspection records and compliance data for Celera Corporation in Walnut Creek, California. 4 FDA inspections on record, last inspected November 24, 2014.
Company Profile
This profile covers Celera Corporation based in Walnut Creek, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected June 12, 2009. Last inspected November 24, 2014.
Most cited issue areas
- Availability1 inspection
- Lack of System for Determining MDR Events1 inspection
- Process changes - review, evaluation and revalidation1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 24, 2014 | NAI | Biologics, Medical Devices & Rad Health · Postmarket Assurance: Devices | 904397 |
| January 9, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 761803 |
| November 5, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 646608 |
| June 12, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 596438 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Celera Corporation
FEI Number
3004008801
Address
2121 N California Blvd Ste 290, Walnut Creek, California 94596, United States
Country
United States
ID: 03a7f1b1-793b-47a3-9a48-d7a5107661e3