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ABAXIS, INC. — FDA Facility Profile

FEI 2939693

ABAXIS, INC. is an FDA-registered facility (FEI 2939693) located in UNION CITY, CA, US. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
UNION CITY, CA (US)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1100338 (VAI Thu Aug 22 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1049551 (NAI Wed Apr 25 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 894936 (NAI Wed Sep 10 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 775878 (NAI Tue Apr 03 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 703154 (NAI Wed Dec 22 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • MC2-6448551-7/6/1 (Mon Jun 09 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • FP1-0008127-1/1/1 (Fri Apr 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 767-0028174-4/1/1 (Mon Nov 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 767-0028174-4/1/2 (Mon Nov 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 767-0028174-4/1/3 (Mon Nov 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources