Dr Reddy’s Laboratories has received a Form 483 from the US Food and Drug Administration (USFDA) after an inspection of its biologics manufacturing facility in Hyderabad.
The regulator issued seven observations, highlighting concerns related to manufacturing practices and quality systems. A Form 483 is issued when inspectors identify conditions that may require corrective action and does not indicate a final regulatory decision.
Dr Reddy’s said it will respond to the observations within the prescribed timeline and work closely with the USFDA to implement necessary corrective and preventive measures.