Drug maker Dr.Reddy's Laboratories has been issued a Form 483 with two observations pertaining to its formulations manufacturing plants in Visakhapatnam by the U.S. Food and Drug Administration (USFDA).
Through Form 483, the regulator intimates the management of the objectionable conditions observed during inspection of a facility that may constitute a violation of the norms.
In a regulatory filing on Saturday, Dr. Reddy's said the "audit of our formulations manufacturing plants (Vizag SEZ Plant 1 and Vizag SEZ Plant 2) at Duvvada, Visakhapatnam by the USFDA, has been completed on June 21."
The company said it has been issued a Form 483 with 2 observations. "We will address them comprehensively within the stipulated timeline," the filing said.
