FDA Inspection
Zevex, Inc.Zevex, Inc. – FDA Inspection, Sep 17, 2018
Record Details
This FDA Inspection record concerns Zevex, Inc., with an inspection on September 17, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2d3b583b-1cef-48c1-b204-350b558d5f5e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1065820
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zevex, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 30, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 30, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 29, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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