Fresenius gets US FDA warning over Indian plant; divests biotech unit

Germany-based Fresenius Kabi has received a warning letter from the US Food and Drug Administration in relation to an inspection of its oncolytic active pharmaceutical ingredients (API) plant in Kalyani, India, conducted in January.

As a precaution, production at the plant was put on hold in January. The letter, dated July 1, details observations related to Good Manufacturing Practice (GMP) non-conformities regarding manufacturing, documentation practices and data integrity. Many of the data integrity items cited in the warning letter were self-identified by Fresenius Kabi post-inspection and shared with the FDA.

In a statement the company said it has made “significant progress” in remedying the issues cited and, based on a detailed remediation action plan submitted to the FDA, it has begun the process of restarting manufacture at the facility. It added: “The company takes this matter very seriously and intends to comprehensively respond in a timely manner to the warning letter.”