# FDA 483 - Abaxis Inc - August 22, 2019

Source: https://www.globalkeysolutions.net/records/483/abaxis-inc/9f23dcc9-c00b-4adb-aebc-99dd41369b78

> FDA 483 for Abaxis Inc on August 22, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abaxis Inc
- Inspection Date: 2019-08-22
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: During an inspection of Abaxis Inc, a medical device manufacturer in Union City, CA, the FDA observed significant deficiencies in the firm's quality system. The company failed to properly identify and report a serious injury event related to an erroneous device reading, and had not conducted a management review of its quality system for over a year.

## Related Documents

- [483 - 2008-08-08](https://www.globalkeysolutions.net/records/483/abaxis-inc/a1abb5d0-e54a-4ee0-91f4-89c4e5e2777a)
- [WARNING_LETTER - 2018-04-25](https://www.globalkeysolutions.net/records/warning_letter/abaxis-inc/26a10076-04ee-4388-a161-34aae1d1b5c7)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/james-a-lane/f6cd3d8d-7de9-45c5-9380-7e0c5de4720e)
- [investigator](https://www.globalkeysolutions.net/people/eric-j-heinze/f16828ab-f1e0-4556-bccc-700d93965b86)

Company: https://www.globalkeysolutions.net/companies/abaxis-inc/98392f88-354f-4be2-b781-a75f289470a2

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b