FDA widens review of Dr. Reddy's manufacturing ops

Dr. Reddy's CEO G.V. Prasad

Dr. Reddy's Laboratories ($RDY) has again come under the spotlight of the U.S. Food and Drug Administration (FDA) which has ordered a third-party audit covering the entire manufacturing network of the company, according to a report by Livemint. India's second-largest pharma maker by sales said the FDA "has given us some areas they would like us to field specifically: it is in the area of third-party evaluation of product quality, and third-party verification of some of the actions we have taken," chief executive officer G.V. Prasad said in the Livemint report. "Any corrective measure we take has to be implemented at all our sites. This is going to take significant effort and time," Prasad said. The report said Prasad disclosed the FDA order three days after the company was warned about possible violations of manufacturing standards at three pharmaceutical plants and said the FDA gave the company 15 days to respond. The company said it is bringing in experts to determine what action it should take, Livemint reported. The warning also means the company will not receive approvals for new drugs made at the plants in question until it fixes the problems. Report