Dr Reddy’s Gets EIR From US FDA For Telangana API Unit; Inspection Closed

Dr. Reddy’s Laboratories said it received an Establishment Inspection Report from the US Food and Drug Administration for its API manufacturing facility (CTO-5) in Miryalaguda, Telangana. The regulator classified the inspection outcome as ‘voluntary action indicated’ and deemed the inspection officially closed.

The facility was inspected between May 19 and 24, following which the US FDA had issued a Form 483 with two observations.