Abaxis IncAugust 22, 2019

FDA 483 - Abaxis Inc - August 22, 2019

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Record Details

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.

Company: Abaxis Inc
Inspection Date: August 22, 2019
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
People: James A. Lane (Investigator)
Eric J. Heinze (investigator)

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ID · 9f23dcc9-c00b-4adb-aebc-99dd41369b78