483
DNA Genotek Inc.DNA Genotek Inc. – FDA 483, Sep 16, 2013
Record Details
An FDA inspection of DNA GENOTEK, INC in Ottawa, Ontario, Canada, a device manufacturer, revealed two significant observations. The firm's design planning procedures were not clearly defined, and a critical functional test for a specific product lacked a written procedure. These issues indicate deficiencies in design control and quality system documentation.
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ID · 5a737ba8-932b-4850-af3e-3acbf0626695
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