FDA Inspection
Norland At SwissrayNorland At Swissray – FDA Inspection, Sep 20, 2010
Record Details
This FDA Inspection record concerns Norland At Swissray, with an inspection on September 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Norland At Swissray
- Inspection Date
- September 20, 2010
- Product Type
- Devices
View Company Profile
ID · 1b6e11b1-482a-4cc0-9c81-c5d98022464b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 681173
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
Full citation text and observation details available on the Dashboard.
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 13, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Norland At Swissray
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.