Another Mylan N.V. (NASDAQ:MYL) manufacturing plant in India is on the spot having been served with a warning letter citing considerable insubordination. The U.S. Food and Drug Administration claims that the company’s quality control processes at the India’s Maharashtra facility have notable integrity issues. The agency points out at concerns relating to the disappearance of batch testing results from computers and apparently, these results involved failed tests.
The warning letter came after an investigation into the facility by the agency and surprisingly it had also been cautioned during an inspection in 2015. In a part of the letter, the agency outlined, “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”
Employees failed to investigate the root cause of the issues
Apparently, the concerns by the agency are not just about the missing testing results. It has also criticized the quality control lab citing that it did nothing to avert the error signals from the HPLC computers. The employees should also have taken up the accountability of thoroughly investigating the causes of these issues but they can hardly explain how this happened.
The agency’s displeasure is in the fact that it has had a discussion with Mylan about similar issues before, which involved three of the sterile injectables plants. Nonetheless, given its extensive experience in generic drugs, the agency now insists that it must develop an action plan, which will be implemented in such issues. Otherwise, it may lead to other dire consequences the likes of withholding of approval of new applications or listing of supplements.
Integrity issues seems to be in every Indian drugmaker
Mylan, which has nine independent sites, has vowed to do better and to cooperate with the FDA in addressing the issues raised. Apparently, it is not alone in integrity issues because Sun Pharmaceutical and Wockhardt have also previously received warning letters. Wockhardt was accused of not bothering to solve similar issues even with ongoing FDA discussions.
It has had three of its plants expelled from shipping to the U.S. In the meantime, Mylan’s stock closed at $38.45 a decline of $0.80 or 2.04%
