FDA EIR - Flowonix Medical Inc - October 11, 2019

An FDA inspection of Flowonix Medical Inc., a Class III Medical Device Manufacturer, occurred from October 10-11, 2019, at their Mansfield, MA facility. This routine Medical Device Level I Inspection, conducted under CP: 7382.845A, concentrated on Corrective and Preventative Actions (CAPA) and Production and Process Controls (P&PC) for their Prometra Programmable Pump and Prometra II Clinical Programmer. The inspection resulted in a 1-item FDA Form 483 for inadequately established complaint procedures. Specifically, three complaints (02662, 02709, 02711) related to the Prometra Pump were kept open for over 120 days without documented justification, a direct violation of the firm's own 'Call, Issue, and Complaint Handling Procedure' and regulatory requirements under 21 CFR 820.198(a). Additionally, the firm was reminded about a previous correction concerning a pump alarm system that was reported 11 working days after initiation. Flowonix Medical Inc. management committed to correcting the observation. The FDA advised that an adequate written response to the 483 observation is required within 15 business days to prevent further regulatory action. The company was found to be properly registered, addressing a previous issue from a 2014 inspection.