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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.