FDA Inspection
Abaxis IncAbaxis Inc – FDA Inspection, Apr 25, 2018
Record Details
This FDA Inspection record concerns Abaxis Inc, with an inspection on April 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Ian A. Pilcher (FDA Associated Person)
- Seema S. Singh (Issuing Officer)
View Company Profile
ID · b33f676a-8144-4285-9696-d193002e595f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1049551
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abaxis Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 3, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 22, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Abaxis Inc
- FDA Inspection 1100338 - 2019-08-22
- FDA Inspection 894936 - 2014-09-10
- FDA Inspection 775878 - 2012-04-03
- FDA Inspection 703154 - 2010-12-22
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.