FDA wants Fresenius to hire a consultant to fix long-standing CGMP woes

The FDA issued a warning letter to one of Fresenius‘ (NYSE:FMS) drug manufacturing plants in India last week, citing concerns that the company has not adequately addressed a sterility problem noted during previous inspections.
It’s not the first time that the Kalyani, India-based manufacturing firm has been hit with a warning. In its letter to Fresenius, the FDA noted that it found in 2015 that the company “invalidated sterility test failures without adequately investigating the root causes, and failed to take timely and appropriate corrective actions.”
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Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat Fresenius Source Type: news