FDA Inspection
Dynarex CorporationDynarex Corporation – FDA Inspection, Mar 31, 2014
Record Details
This FDA Inspection record concerns Dynarex Corporation, with an inspection on March 31, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dynarex Corporation
- Inspection Date
- March 31, 2014
- Product Type
- Devices
View Company Profile
ID · 6589409d-ab00-4105-8028-80baa9aab4dc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 873247
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Dynarex Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2018 | Not classified | New York District Office | |
| March 2, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 20, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Dynarex Corporation
- FDA Inspection 1102050 - 2018-11-16
- FDA Inspection 1005494 - 2017-03-02
- FDA Inspection 762080 - 2011-12-20
- FDA Inspection 567627 - 2009-02-20
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