FDA WARNING_LETTER - InfuTronix LLC - February 15, 2022

The FDA issued a Warning Letter to InfuTronix following an inspection from January 29 to February 15, 2022, at their Natick, MA facility, which manufactures infusion pumps and administration sets. The inspection revealed that the firm's devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) and § 352(o).

Significant QS violations include failure to analyze quality data and employ statistical methods for recurring problems (21 CFR 820.100(a)(1)), inadequate complaint handling procedures (21 CFR 820.198(a)), and failure to investigate device failure complaints (21 CFR 820.198(c)). Additionally, the firm failed to report a correction/removal of Nimbus II PainPRO pumps with an unreleased library configuration within 10 days (21 CFR 806.10) and lacked adequate Medical Device Reporting (MDR) procedures (21 CFR 803.17). Furthermore, InfuTronix Administration Sets were found adulterated and misbranded because significant design and labeling changes were made post-510(k) clearance without new premarket approval or notification (21 U.S.C. § 360e(a), § 360(k)).

Despite multiple responses from the firm outlining corrective actions, the FDA deemed them inadequate as actions were incomplete and timelines undefined. InfuTronix must provide a comprehensive response within 15 business days detailing specific, systemic corrective actions, supporting documentation, and a timetable. Failure to comply may result in regulatory actions such as seizure, injunction, civil penalties, and impact on federal contracts or device approvals.