Enlarge / Heather Bresch, chief executive officer of drugmaker Mylan Inc. (credit: Getty | Bloomberg)
Mylan—the pharmaceutical company infamous for raising the price of EpiPens—is in hot water with the Food and Drug Administration. This time, the dust-up is related to the quality control practices at one of the company’s drug facilities making antiretroviral therapies (ARVs) used to treat HIV, Reuters reports.
In a letter to Mylan, the FDA outlined several violations at the facility, based in Maharashtra, India, and warned Mylan to shape up. Specifically, the FDA said that investigators found that facility employees inexplicably invalidated quality control data that showed that drug batches didn’t meet standards. The agency also claimed that employees didn’t bother trying to investigate those failures or prevent them from reoccurring.
“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 wrote. The letter was dated April 3, but it was released by the agency Tuesday.
Read 5 remaining paragraphs | Comments
