Drugs

Zydus Lifesciences Issued Another FDA-483

An FDA inspection conducted 4/15-4/23 at Zydus Lifesciences’ injectable manufacturing site in Jarod, India resulted in a 10-observation Form FDA-483, according to a company financial release. “The company will closely work with the U.S. FDA to address and respond to the observations in an expeditious manner,” it says.

This is the second FDA-483 issued to the company over the past month. The agency issued Zydus Lifesciences a four-item Form FDA-483 after inspecting the firm’s manufacturing facility in Gujarat, India. The form said Zydus’ aseptic processing areas are deficient, specifically its system for monitoring environmental conditions. For example, it said that from 5/23 to 12/2023 the firm manufactured and distributed human drug products intended to be sterile when its environmental monitoring program for viable microorganisms was not in a state of control.

Additionally, the inspection found that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written and followed. And, FDA said, buildings used in the manufacturing, processing, packing and holding of drug prroducts are not maintained in a good state of repair. For example, the roof of the building that covers the aseptic filling line had multiple holes in it and the sky could be seen through the holes.

Zydus (formerly known as Cadila Healthcare) has been in FDA hot water over the past few years. In 2022, Viona Pharmaceuticals recalled 33 lots of Cadila-manufactured metformin HCl extended-release tablets 750 mg due to an out-of-specification result observed for the product that detected N-nitrosodimethylamine. An agency notice says the product was manufactured by Cadila’s Ahmedabad, India facility for U.S. distribution by Viona.

And in 2019, FDA issued a Warning Letterafter an inspection cited significant GMP violations. The letter also acknowledged a 10/2/2019 communication informing FDA that the company would permanently cease production of injectable drug products for the U.S. “It is important to note that full remediation of the related CGMP violations cited will be necessary if you decide to resume the manufacturing of injectable drug products at this site, or if any successor firm assumes responsibility over the site’s operation in the future,” the agency wrote then.

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