FDA Inspection
Cepheid AbCepheid Ab – FDA Inspection, Mar 31, 2015
Record Details
This FDA Inspection record concerns Cepheid Ab, with an inspection on March 31, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cepheid Ab
- Inspection Date
- March 31, 2015
- Product Type
- Devices
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ID · 8412a280-37da-4db1-8771-2513f3a906a3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 921587
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of Cepheid Ab
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cepheid Ab
- FDA Inspection 1006012 - 2017-03-15
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