InfuTronix LLC

Warning LetterOpen

Chaoyoung Lee CEO & Founder InfuTronix LLC 177 Pine Street Natick , MA 01760 United StatesFEI 3011581906Issued Jun 16, 2022Office of Medical Devices and Radiological Health Operations Div. 1 East

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3011581906.

Letter Details

Firm: InfuTronix LLC
Location: Chaoyoung Lee CEO & Founder InfuTronix LLC 177 Pine Street Natick , MA 01760 United States
FEI Number: 3011581906
Country: United States
Issue Date: June 16, 2022
Issuing Office: Office of Medical Devices and Radiological Health Operations Div. 1 East
Product Type: Medical Devices
Status: Open

Summary

InfuTronix LLC, a manufacturer of infusion pumps and associated administration sets including the Nimbus II Pain PRO and Halo II systems, was found to produce adulterated devices that failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. The company's most significant violation was a failure to adequately analyze quality data sources—including process data, audit reports, quality records, service records, and customer complaints—to identify existing and potential causes of non-conforming products. An FDA inspection conducted January 29 through February 15, 2022, documented these deficiencies, and despite the company's submission of four corrective action responses between March and June 2022, the violations remained unresolved.