Dr. Reddy’s API unit issued Form 483 with 7 observations by U.S. FDA 

An active pharmaceutical ingredients manufacturing facility of generic drugmaker Dr. Reddy’s Laboratories in Hyderabad has received seven observations from the U.S. Food and Drug Administration (U.S. FDA).

“We have been issued a Form 483 with 7 observations, which we will address within the stipulated timeline,” Dr. Reddy’s said in a filing on Tuesday. It was a GMP inspection of the API manufacturing facility (CTO-2) in Bollaram, Hyderabad. The inspection was conducted from November 13-19, it said.