FDA Inspection
Dynarex CorporationDynarex Corporation – FDA Inspection, Mar 2, 2017
Record Details
This FDA Inspection record concerns Dynarex Corporation, with an inspection on March 2, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d9f02058-88a3-4ffb-8942-59d6cb8fdea0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005494
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Dynarex Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2018 | Not classified | New York District Office | |
| March 31, 2014 | 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 873247 - 2014-03-31
- FDA Inspection 762080 - 2011-12-20
- FDA Inspection 567627 - 2009-02-20
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