Company
United StatesCepheid, Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Cepheid in Sunnyvale, California. 5 FDA inspections on record, last inspected August 09, 2017.
Company Profile
This profile covers Cepheid based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected September 16, 2009. Last inspected August 9, 2017.
Most cited issue areas
- Complaints1 inspection
- Design validation - user needs and intended uses1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 9, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1026773 |
| June 16, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 928802 |
| January 13, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 763635 |
| October 29, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 695802 |
| September 16, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 612704 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cepheid
FEI Number
3004530258
Address
904 E Caribbean Dr, Sunnyvale, California 94089, United States
Country
United States
ID: b8ab5e76-7447-435e-a3e3-c387ac1c40ec