Hyderabad-based Vista Pharmaceuticals has received a warning letter from the U.S. FDA for significant cGMP violations for finished pharmaceuticals at its manufacturing plant in Telangana.
Vista's Telangana plant is its only facility exporting drugs to U.S. market.
According to the Warning Letter, during the September 2016 inspection, FDA officials found equipment to be corroded and in a state of disrepair. Prior to the inspection, in March 2016, the FDA received a complaint of metal embedded in one of the drugmaker's tablets.
Vista also failed to establish written procedures for production and process control and received an additional labelling violation related to a generic vasodilator isoxsuprine hydrochloride.
Vista responded to the observations last October with a corrective action plan, but has still failed to convince the FDA that the appropriate corrective actions have been taken. According to an updated Economic Times article, Vista said it is addressing all the issues raised in the Warning Letter.
Read the Warning Letter