USFDA Closes Zydus Lifesciences Inspection with 2 Observations
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USFDA completed a follow-up inspection of Zydus Lifesciences' oncology injectable unit in Ahmedabad, issuing two observations. No data integrity issues were found.
Photograph: Courtesy Zydus.
New Delhi, Jun 18 (PTI) Zydus Lifesciences Ltd on Wednesday said the USFDA has closed follow-up inspection of its oncology injectable site near Matoda in Ahmedabad with two observations.
The US Food and Drug Administration (USFDA) had conducted a GMP follow-up inspection at the company's oncology injectable site situated at SEZ 1, near Matoda, Ahmedabad, from June 9-18, 2025, the company said in a regulatory filing.
"The inspection is closed with two observations, and none of them were related to data integrity," it added.
Zydus Lifesciences further said it will closely work with the USFDA to address and respond to the observations in an expeditious manner.
The US Food and Drug Administration (USFDA) had conducted a GMP follow-up inspection at the company's oncology injectable site situated at SEZ 1, near Matoda, Ahmedabad, from June 9-18, 2025, the company said in a regulatory filing.
"The inspection is closed with two observations, and none of them were related to data integrity," it added.
Zydus Lifesciences further said it will closely work with the USFDA to address and respond to the observations in an expeditious manner.
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