Warning letter woes: Dr Reddy’s expects FDA inspection of AP plant by year-end

US FDA had issued warning letter in November 2015 relating to Current Good Manufacturing Practice deviations at Dr Reddy’s API manufacturing facilities at Srikakulam.

Dr Reddy’s Laboratories was expecting an inspection of its Active Pharmaceuticals Ingredients (API) plant at Srikakulam in Andhra Pradesh by the US Food and Drug Administration officials by the end of this year, a top company official said.

“On the regulatory front, the API plant at Miryalaguda was given an Establishment Inspection Report (EIR) in 2017 resolving the earlier warning letter. We also received EIR for the injectable site at the Duvvada and we are awaiting for CTO VI site at Srikakulam. And based on discussions, we expect an inspection (by the FDA) later this year and hopeful for the resolution of the matter,” Co-Chairman, Managing Director and CEO GV Prasad told shareholder in the Annual General Meeting held here.