483
Flowonix Medical IncFlowonix Medical Inc – FDA 483, Oct 11, 2019
Record Details
An FDA inspection of Flowonix Medical Inc. in Mansfield, MA, revealed inadequate procedures for handling complaints. Specifically, several complaints concerning the Prometra Pump remained open for over 120 days without documented justification, violating the firm's own complaint procedure. This indicates a significant lapse in the firm's quality system for complaint management.
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ID · d9e4774a-68fd-465d-bd77-8b6fa679ca84
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