FDA Inspection
Zevex, Inc.Zevex, Inc. – FDA Inspection, Apr 13, 2017
Record Details
This FDA Inspection record concerns Zevex, Inc., with an inspection on April 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Christine I. Shaw (Company Rep)
- Kathleen S. Tormey (Investigator)
- Kimberly Lewandowski-Walker (Issuing Officer)
- Matthew M. Vernon (Company Rep)
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ID · c6bcbf52-fc06-4be4-b797-a86af1307799
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1010305
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(e)Documentation
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zevex, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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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