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The US drug regulator issued a Form 483 with four observations after an August 6-14 inspection of Dr Reddy’s Bachupally formulations facility. The company said it will respond within the stipulated timeline.
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Dr Reddy’s Laboratories received four observations from the US Food and Drug Administration following an inspection of its formulations manufacturing facility in Bachupally, Hyderabad.
The US drug regulator conducted a Good Manufacturing Practices inspection of the company’s FTO-3 facility from August 6 to August 14, Dr Reddy’s said in an exchange filing.
The inspection concluded with the FDA issuing a Form 483 containing four observations. Dr Reddy’s didn’t disclose the nature of the observations or indicate whether they could have any impact on operations at the facility.
The company said it would address the observations within the stipulated timeline.
What is a Form 483?
The FDA issues a Form 483 at the conclusion of an inspection when investigators observe conditions that, in their judgment, may constitute violations of US regulatory requirements.
A Form 483 isn’t a final determination by the FDA. Companies are generally given an opportunity to respond to the observations and outline corrective measures before the regulator determines whether further action is warranted.
Dr Reddy’s filing didn’t provide additional details about the four observations beyond stating that they arose from the GMP inspection of the Bachupally facility.
The company disclosed the development under Regulation 30 of the Securities and Exchange Board of India’s listing regulations.
Dr Reddy’s shares closed Friday at ₹1,200 on the NSE, down 0.5% from the previous session.
