Company
United StatesZevex, Inc., Salt Lake City, UT – FDA Inspections
Inspection records and compliance data for Zevex, Inc. in Salt Lake City, Utah. 7 FDA inspections on record (3 OAI), 2 Form 483s, last inspected September 17, 2018.
Company Profile
This profile covers Zevex, Inc. based in Salt Lake City, Utah, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 3
- VAI
- 2
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected June 15, 2009. Last inspected September 17, 2018.
Most cited issue areas
- Lack of or inadequate procedures5 inspections
- Documentation4 inspections
- Individual Report of Malfunction4 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1065820 |
| April 13, 2017 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1010305 |
| July 30, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 938132 |
| August 30, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 797053 |
| October 14, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 752747 |
| December 29, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 704438 |
| June 15, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 589022 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Zevex, Inc.
FEI Number
1000117172
Address
4314 S Zevex Park Ln, Salt Lake City, Utah 84123, United States
Country
United States
ID: 59d978f3-677b-4233-b46a-801d6e70bb56