A formulations manufacturing plant of pharma major Dr. Reddy’s Laboratories in Hyderabad was issued Form 483 with 11 observations by the US Food and Drug Administration on Friday.
“The audit of our formulations manufacturing plant-3 at Bachupally was completed today. We have been issued Form 483 with 11 observations. We will address them comprehensively within the stipulated time,” Dr. Reddy’s said.
The US regulator, through a Form 483, notifies objectionable conditions, which may constitute violation of the provisions.
About 10 days ago, the American regulator had issued a Form 483 with one observation to the API manufacturing plant of Dr. Reddy’s Laboratories in Miryalaguda.
