U.S. FDA warns Mylan about alleged violations at India facility | Chemical & Engineering News
Volume 95 Issue 17 | p. 14 | Concentrates
Issue Date: April 24, 2017

U.S. FDA warns Mylan about alleged violations at India facility

By K. V. Venkatasubramanian, special to C&EN
Department: Government & Policy
Keywords: pharmaceuticals, Mylan, India, FDA

Generic drug maker Mylan has received a warning from FDA about alleged failure to control drug quality, significant violations of manufacturing standards, and data integrity lapses at a facility in India. The facility produces antiretroviral therapies used to treat HIV infection. In an April 3 letter, the agency says its investigator, who inspected the Nashik factory in India’s western state of Maharashtra, allegedly found significant violations of current Good Manufacturing Practice regulations for finished pharmaceuticals. “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 letter says. The agency adds that failure to correct these violations may result in FDA refusing admission into the U.S. of items produced at the plant. In 2015, FDA expressed concerns over quality controls at three Mylan factories in Bengaluru, in south India.

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