Company
United StatesAbaxis Inc, Union City, CA – FDA Inspections
Inspection records and compliance data for Abaxis Inc in Union City, California. 5 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected August 22, 2019.
Company Profile
This profile covers Abaxis Inc based in Union City, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 3
- Form 483s
- 2
- Warning letters
- 1
First inspected December 22, 2010. Last inspected August 22, 2019.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Evaluation, timeliness, identification1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1100338 |
| April 25, 2018 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1049551 |
| September 10, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 894936 |
| April 3, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 775878 |
| December 22, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 703154 |
FDA documents
Warning Letters (1)
EIRs (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Abaxis Inc
FEI Number
2939693
Address
3240 Whipple Rd, Union City, California 94587, United States
Country
United States
ID: 98392f88-354f-4be2-b781-a75f289470a2