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12 April 2017, 10:58
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'Mylan NV' Facility In India Making HIV Drugs Ignored Bad Quality Control Data, FDA Says

'Mylan NV' Facility In India Making HIV Drugs Ignored Bad Quality Control Data, FDA Says - picture 1

Mylan NV — the pharmaceutical company infamous for raising the price of EpiPens—is in trouble the U.S. Food and Drug Administration (FDA). This time, the scandal is linked to the quality control practices at a Mylan NV manufacturing plant in Maharashtra, India making antiretroviral therapies (ARVs) used to treat HIV, Reuters reports.

"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," the FDA claimed in a letter dated April 3, “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,” paying attention to the fact that workers didn’t bother trying to investigate those failures or prevent them from reoccurring.

A Mylan NV's India-based drug manufacturing facilities have been criticized by the FDA in recent years for violating quality standards, as the agency increases oversight of key suppliers to the United States.

Author: Lilia Ten

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