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Zydus Lifesciences' Ahmedabad unit under USFDA observation

Zydus Lifesciences' Ahmedabad unit under USFDA observation

Zydus Lifesciences informed that the USFDA conducted an inspection at the manufacturing facility Zydus Animal Health and Investments, located at SEZ, Ahmedabad. The inspection was conducted between September 23 to September 29, 2022.

This is a new specialised animal health manufacturing plant that will serve the US and other regulated markets.

The inspection was a Pre-Approval Inspection (PAI), which resulted in two observations. None of these observations had anything to do with data integrity. The corporation will address the observations in a timely manner in collaboration with the regulators, said Zydus in its regulatory filing.

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USFDA Zydus Lifesciences
More news about: quality / gmp | Published by Sudeep Soparkar | September - 30 - 2022 | 891

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