FDA Inspection
Zevex, Inc.Zevex, Inc. – FDA Inspection, Oct 14, 2011
Record Details
This FDA Inspection record concerns Zevex, Inc., with an inspection on October 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zevex, Inc.
- Inspection Date
- October 14, 2011
- Product Type
- Devices
View Company Profile
ID · bc0ce7f4-b9d6-48f3-9d26-d71ac1a82514
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 752747
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, 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 |
|---|---|---|---|
| September 17, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
| December 29, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zevex, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.