Zydus Ahmedabad facility gets 4 USFDA observations

Published On 2022-08-06 05:56 GMT   |   Update On 2022-08-06 05:56 GMT
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Ahmedabad: 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 at Ahmedabad.

The inspection was conducted from 26th July to 5th August 2022.

"We wish to inform 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.
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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. 

"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.

Read also: Zydus Lifesciences bags USFDA nod for Ivermectin Cream for treatment of inflammatory lesions of rosacea

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