USFDA issues 9 observations for Dr Reddy's Labs Hyderabad facility
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Hyderabad: Pharma major, Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has concluded a product specific Pre-Approval Inspection (PAI) with nine observations at the Company's biologics manufacturing facility in Bachupally, Hyderabad.
The inspection was conducted from October 4, 2023 to October 12, 2023.
"We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline," the Company stated in a BSE filing.
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