USFDA issues 3 observations for Zydus Lifesciences's Vadodara plant

Written by MD Bureau Published On 2022-03-11T14:36:34+05:30 | Updated On 11 March 2022 2:36 PM IST

USFDA issues 3 observations for Zydus Lifesciencess Vadodara plant

"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network," Zydus Lifesciences stated.

New Delhi: Zydus Lifesciences on Thursday said the US health regulator has issued three observations after inspecting its Jarod (Vadodara) based manufacturing facility. The US Food and Drug Administration (USFDA) inspected the injectable facility from February 24 to March 10, 2022.

The inspection closed with three observations, the drug firm said in a regulatory filing.

"We are confident of addressing and resolving the issues to the satisfaction of USFDA. We remain committed to building a quality culture across our entire manufacturing network, and are committed to remain compliant with high standards of good manufacturing practices across our network," Zydus Lifesciences stated.

As per the US health regulator, an FDA Form 483 (observation) is issued to a firm's management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of Food Drug and Cosmetic (FD&C) Act and related Act.

USFDA issues its observations through Form 483 at the conclusion of an inspection if the investigators have observed any conditions that may violate current good manufacturing practices.

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Cadila Pharmaceuticals Ltd. is the privately-held pharmaceutical company in India. Over the past seven decades, Zydus has been developing and manufacturing affordable medicines for patients around the world.

The innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.

Being a care-focused, research-driven company, Cadila is committed to complying with the highest ethical standard in clinical research and medical practice. Cadila wants to be valued not only for our pharmaceutical products but also for the way we conduct our research and business activities.

USFDAZydus LifesciencesVadodara plantFood Drug and Cosmetic ActUS Food and Drug Administrationinspection

Source : PTI

MD Bureau

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