FDA Inspection
Norland At SwissrayNorland At Swissray – FDA Inspection, Sep 13, 2011
Record Details
This FDA Inspection record concerns Norland At Swissray, with an inspection on September 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Norland At Swissray
- Inspection Date
- September 13, 2011
- Product Type
- Devices
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ID · c56e65b1-f1f9-4a46-bda0-7bce0a88a7ea
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 742300
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Norland At Swissray
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 30, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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