483
Flowonix Medical IncFDA 483 - Flowonix Medical Inc - October 11, 2019
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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