FDA Inspection
Misonix, Inc.Misonix, Inc. – FDA Inspection, Dec 14, 2015
Record Details
This FDA Inspection record concerns Misonix, Inc., with an inspection on December 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Misonix, Inc.
- Inspection Date
- December 14, 2015
- Product Type
- Devices
View Company Profile
ID · 717bf6d4-54de-4652-b030-24a2ac0ffb03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 952742
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40(a)Document review, approval by designated individual
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 |
| October 10, 2014 | 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 898643 - 2014-10-10
- FDA Inspection 781232 - 2012-04-26
- FDA Inspection 657067 - 2010-03-25
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