FDA Warns Fresenius Kabi API Manufacturing Plant
By Zachary Brennan -
Published 02 January 2018
The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi’s active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies.
Categories: News, India, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing
Tags: Fresenius, warning letter, API manufacturing
FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials
By Michael Mezher -
Published 15 February 2017
The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.
Categories: News, US, CBER, Advertising and Promotion, Blood, Compliance, Drugs
Tags: Fenwal, Fresenius Kabi, InterSol, Amicus, Promotional Materials