# FDA 483 - Abaxis Inc - August 08, 2008

Source: https://www.globalkeysolutions.net/records/483/abaxis-inc/a1abb5d0-e54a-4ee0-91f4-89c4e5e2777a

> FDA 483 for Abaxis Inc on August 08, 2008. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Abaxis Inc
- Inspection Date: 2008-08-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Abaxis, Inc., a medical device manufacturer in Union City, CA, was cited for significant deficiencies across its quality system. The inspection revealed failures in controlling non-conforming products, establishing and implementing complaint handling and corrective/preventive action procedures, and adhering to medical device reporting requirements. These issues indicate a systemic lack of adherence to quality system regulations, potentially impacting product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2018-04-25](https://www.globalkeysolutions.net/records/warning_letter/abaxis-inc/26a10076-04ee-4388-a161-34aae1d1b5c7)
- [483 - 2019-08-22](https://www.globalkeysolutions.net/records/483/abaxis-inc/9f23dcc9-c00b-4adb-aebc-99dd41369b78)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/juan-morales/ffaf4025-0b5d-46d8-9f50-4215b7b5d63f)

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