Last Updated on December 31, 2023 by The Health Master
Zydus Lifesciences has recently announced that the US Food and Drug Administration (USFDA) has issued four observations after the inspection of the company’s Moraiya manufacturing facility located in Ahmedabad.
The inspection was conducted from 26th July to 5th August 2022.
“We wish to inform you that the USFDA conducted an inspection of our Moraiya manufacturing facility located at Ahmedabad from 26th July to 5th August 2022. The inspection concluded with four Form 483 observations,” the company stated in a BSE filing.”
A USFDA 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.
“None of the observations were related to data integrity. The company will address the observations within the stipulated timeline,” Zydus added.”
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs.
Zydus Group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US, and Brazil.
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