FDA warning letter over issues at ex-Ivenix site: Fresenius Kabi

Fresenius Kabi received a warning letter related to large-volume infusion pumps acquired through its $240 million takeover of Ivenix. The FDA cited delays in completing corrective actions and the absence of established procedures. Inspectors visited the Massachusetts site five months after Fresenius initiated a recall of Ivenix infusion pumps due to a leak risk. The acquisition aimed to strengthen Fresenius' U.S. medtech business and support growth plans. However, since the 2022 takeover, Fresenius faced quality issues, resulting in three Class I recalls and an FDA warning letter. The FDA noted inadequacies in investigating a software bug that led to the first Class I recall and in verifying corrective actions for the leak issue triggering the second. Failures in procedure establishment and maintenance were also addressed. Fresenius responded to FDA concerns but some were deemed inadequate, prompting further review.