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.”
“Although you proposed remediations in your responses following the 2015 inspection, and discussed these plans during a 2016 regulatory meeting with the Agency, our current inspection found that your facility’s oversight and control over the manufacture of drugs remains deficient,” the regulatory agency added.
In its warning letter, the FDA specifically highlighted a test performed in January last year that found potential bacterial contamination. Fresenius conducted an investigation and concluded that the sterility failure was caused by a laboratory error, but the FDA said Fresenius did not do enough to thoroughly investigate “any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed.”
The FDA closed its warning letter with a recommendation that Fresenius hire a consultant to help it meet CGMP requirements.
A spokesperson for the company has told a number of news outlets over the last week that the company has responded to the FDA’s letter and that it is engaging with external consultants.