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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Medical Dialogues team had earlier reported that the USFDA had completed an inspection with ten observations at the company's formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.

Read also: Dr Reddy's Labs gets 10 USFDA observations for Bachupally facility

Established in 1984, Dr Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The company offers a portfolio of products and services, including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddys major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

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