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Manufacturing Issues Lead to Second FDA Form 483 for Zydus Lifesciences

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Zydus Lifesciences has received its second Form 483 from the FDA within a month, pointing out several critical manufacturing issues. The latest inspection of the company’s facility in Gujarat, India, conducted between April 15 and April 23, revealed ten observations, which were detailed in a report posted by the FDA on April 29.

The FDA’s inspection identified a range of problems, including unqualified employees performing sample collections and inadequate evaluations of drug batches. The agency noted inconsistencies in internal investigations, non-compliance with sampling plans, and failures to adhere to procedures designed to prevent microbiological contamination of sterile drug products. These issues were considered serious enough to warrant regulatory action.

One significant concern was that even after an investigation revealed cross-contamination in rejected batches, other drug lots produced on the same equipment were released to the U.S. market without a thorough investigation. This oversight could potentially compromise the safety and efficacy of the products.

FDA Cites Manufacturing Protocol Breaches in Second Form 483 for Zydus Lifesciences

A particularly troubling example cited by the FDA involved an employee who falsely claimed to have collected samples, delegating the task to a staff member who was not qualified to perform it. This breach of protocol raises questions about the reliability of the company’s quality control processes.

The FDA also raised concerns about Zydus’ lack of written procedures to ensure that products meet the required strength, purity, and quality standards. Additionally, the inspection revealed that equipment and utensils were not regularly cleaned, increasing the risk of contamination.

This recent Form 483 represents the second FDA citation for Zydus in a short period. Last month, the agency issued another Form 483 following a March inspection of Zydus’ facility in Matoda, India. During that inspection, the FDA noted four observations, including failures to clean and maintain equipment and a lack of procedures to prevent microbiological contamination of sterile products.

Manufacturing

Ongoing Manufacturing Issues at Zydus Highlight Need for Compliance with FDA Regulations

The repeated citations indicate ongoing issues within Zydus’ manufacturing processes that need to be addressed to comply with FDA regulations and ensure the safety and quality of their pharmaceutical products. The company’s ability to rectify these issues promptly will be crucial in maintaining its standing with the FDA and continuing to supply products to the U.S. market.

These findings underscore the importance of rigorous quality control and adherence to regulatory standards in pharmaceutical manufacturing. As Zydus works to address the FDA’s concerns, the industry will be closely watching to see how the company responds and whether it can implement the necessary changes to meet the required standards.

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Resource: Fierce Pharma, May 06, 2024

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