USFDA issues 2 observations on Form 483 to Zydus Lifesciences

The inspection took place from September 23 through September 29, 2022.

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USFDA Inspection audit Form 483
USFDA Form 483

Zydus Lifesciences has recently announced that the US Food and Drug Administration (USFDA) has concluded a Pre-Approval Inspection (PAI) with two observations at the SEZ, Ahmedabad facility of Zydus Animal Health and Investments Limited (a wholly owned subsidiary of Zydus Lifesciences Limited). 

This is a new manufacturing facility for the animal health business, which will cater to the US and other regulated markets.

The inspection took place from September 23 through September 29, 2022.

None of these observations were related to data integrity.

In a recent BSE filing, Zydus Lifesciences stated, “The company will address the observations within a stipulated timeline working with the regulators.”

With its headquarters in Ahmedabad, India, Zydus Group is the fourth-ranked pharmaceutical company in that country.

The 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.

Zydus‘ global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and the high-profile markets of Latin America and South Africa.

It is also present in a big way in 25 other emerging markets worldwide.

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