FDA Inspection
Misonix, Inc.Misonix, Inc. – FDA Inspection, Oct 10, 2014
Record Details
This FDA Inspection record concerns Misonix, Inc., with an inspection on October 10, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Misonix, Inc.
- Inspection Date
- October 10, 2014
- Product Type
- Devices
View Company Profile
ID · cf83c967-a408-4f62-b85f-412679dbe589
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 898643
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.65Traceability Lack of or inadequate {see also 820.120(e)}
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Misonix, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 14, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 26, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 25, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Misonix, Inc.
- FDA Inspection 1017560 - 2017-05-19
- FDA Inspection 952742 - 2015-12-14
- FDA Inspection 781232 - 2012-04-26
- FDA Inspection 657067 - 2010-03-25
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