Drugs

Zydus Gets ‘Official Action Indicated’ on Recent Inspection

FDA has classified as “official action indicated” an April inspection of Zydus Lifesciences’ injectables manufacturing facility at Jarod, Gujarat, India. The company says it will “work closely with the agency to resolve the regulatory status of this facility expeditiously.”

The inspection resulted in a 10-item Form FDA-483 that cited significant GMP violations. For example, the agency said investigations for cross-contamination due to inadequate cleaning were not thorough in evaluating all impacted batches. Also, FDA cited Zydus for failing to follow established sampling plans and test procedures. Additionally, it failed to establish adequate written procedures for production and process controls, and appropriate controls are not exercised over computers or related systems to assure that changes in master production or other records are instituted only by authorized personnel, the inspection report said.

In March, FDA issued the firm a Form FDA-483 after inspecting its manufacturing facility in Gujarat, India. The form said Zydus’ aseptic processing areas were deficient, specifically its system for monitoring environmental conditions. That inspection also found that procedures designed to prevent microbiological contamination of drug products purporting to be sterile were not written and followed. And, FDA said, buildings used in the manufacturing, processing, packing and holding of drug products were 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) appears to have been receiving increasing FDA attention 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 said 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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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome