Dr Reddy's Labs gets 3 USFDA observations for Bachupally RnD centre
Hyderabad: Drug major Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has issued three observations at the completion of a GMP and Pre-Approval Inspection (PAI) at the Company's R&D centre (Integrated Product Development Organisation or IPDO) in Bachupally, Hyderabad.
The inspection was conducted from December 4, 2023 to December 8, 2023.
"We have been issued a Form 483 with three observations, which we will address within the stipulated timeline," Dr Reddy's informed through a recent BSE filing.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
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