483
Abaxis IncAbaxis Inc – FDA 483, Aug 22, 2019
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.
View Company Profile
ID · 9f23dcc9-c00b-4adb-aebc-99dd41369b78
Other documents for Abaxis Inc
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.