Company
SwedenCepheid Ab, Solna, Sweden – FDA Inspections
Inspection records and compliance data for Cepheid Ab in Solna. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected March 15, 2017.
Company Profile
This profile covers Cepheid Ab based in Solna, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 1
First inspected March 31, 2015. Last inspected March 15, 2017.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Purchasing controls, Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 15, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1006012 |
| March 31, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 921587 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cepheid Ab
FEI Number
3009613136
Address
Rontgenvagen 5, Solna, Sweden
Country
Sweden
ID: 48a61883-847a-41e2-acfb-c883150591f1