Dr Reddy’s Labs gets 2 USFDA observations for Duvvada facilities
Hyderabad: Dr Reddy’s Labs has informed in a recent BSE filing, that the United States Food & Drug Administration (USFDA) has concluded a routine GMP inspection with two observations at the Company’s formulations manufacturing facilities (FTO-7 &
FTO-9) in Duvvada, Visakhapatnam.
The inspection was conducted from 8th May to 17th May,
2024.
“We have been issued a Form 483 with two observations, which we will address within
the stipulated timeline,” the Company stated in a 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.
Established in 1984, Dr Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Dr Reddys 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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