Dr. Reddy’s Hyderabad unit gets 11 US FDA Form 483 observations for violations
Mumbai: Dr. Reddy’s Laboratories Ltd said on Friday that the US Food and Drug Administration (FDa) has issued a Form 483 to its formulations manufacturing plant-3 at Bachupally in Hyderabad with 11 observations relating to deviations from good manufacturing practices.
“The observations are mostly procedural in nature, reflecting the need to improve people capabilities and strengthen documentation and laboratory systems,” Dr. Reddy’s said in a stock exchange filing.
The FDA issues a Form-483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.
The audit of the plant was completed on Friday and the company said it will address the observations comprehensively and respond to the regulator within the stipulated time.
The Bachupally site has three units that in all contribute 40-50% to Dr. Reddy’s US sales, Amey Chalke, research analyst, pharma, HDFC Securities said. “We need more clarity from the company on how much is plant-3’s sales contribution and details of the observations,” he added.
On Friday, shares of Dr. Reddy’s ended up 0.2% at Rs2,599.15 on the BSE, while the benchmark Sensex index closed 0.4% lower at 29918.40 points.