FDA warns Mylan about alleged violations at India facility “” 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.
by K. V. Venkatasubramanian, special to C&EN |
April 24, 2017