FDA EIR - InfuTronix LLC - April 05, 2018

An FDA inspection of InfuTronix LLC, a Class II medical device manufacturer based in Natick, MA, was conducted from March 27-28 and April 5, 2018. This represented the initial inspection for the company, performed under a Risk-Based Work Plan inspection (CP: 7382.845H). InfuTronix LLC specializes in designing various Nimbus II Ambulatory Infusion Systems and associated administration sets, with manufacturing outsourced to contract partners. The inspection specifically reviewed the firm's Management Controls, Corrective and Preventative Actions (CAPA), and Design Controls, with a focus on the Nimbus II PainPRO system and all design changes. Notably, the inspection concluded with no issues warranting an FDA-483 observation, indicating strong adherence to regulatory standards. While no formal violations were cited, discussions were held with management regarding minor administrative points, specifically the incompleteness observed in some complaint and Return Material Authorization (RMA) forms. Management collectively acknowledged and understood these concerns. The overall outcome was positive, confirming InfuTronix LLC's compliance with regulatory frameworks for medical device design and quality system management, with no formal required actions beyond the noted administrative discussions.