FDA Inspection
Abaxis IncAbaxis Inc – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns Abaxis Inc, with an inspection on August 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f15efc1c-a332-4496-bf72-54378aaa76ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abaxis Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 25, 2018 | OAI | 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 1049551 - 2018-04-25
- FDA Inspection 894936 - 2014-09-10
- FDA Inspection 775878 - 2012-04-03
- FDA Inspection 703154 - 2010-12-22
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