FDA Inspection
Medinol Ltd.Medinol Ltd. – FDA Inspection, Mar 31, 2014
Record Details
This FDA Inspection record concerns Medinol Ltd., with an inspection on March 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medinol Ltd.
- Inspection Date
- March 31, 2014
- Product Type
- Devices
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ID · b54d92a9-b5a4-4c8d-9ad0-3b9f98606f22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 876543
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Medinol Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2017 | Not classified | Office of Inspections and Investigations | |
| June 9, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Medinol Ltd.
- FDA Inspection 1041900 - 2017-08-28
- FDA Inspection 733413 - 2011-06-09
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