Dr Reddy’s informed the Indian National Stock exchange on 28 October 2023 that the FDA issued a Form 483 with ten observations for Dr Reddy’s biologics manufacturing facility in Hyderabad. The observations were issued as part of a routine cGMP inspection of the facility by the FDA between 19 and 27 October 2023. Dr Reddy’s confirmed in the announcement that it will address all ten observations within the stipulated timeline.
On 12 October 2023, the FDA issued a Form 483 with nine observations regarding that same Dr Reddy’s biologics manufacturing facility, after a product-specific pre-approval inspection by the FDA between 4 and 12 October.