The U.S. Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) to Zydus Lifesciences, an injectable facility based in Vadodara, India. The report, which was issued with a Voluntary Action Indicated (VAI) classification, is a result of a Good Manufacturing Practice (GMP) follow-up inspection conducted by the U.S. FDA at the facility from August 25 to September 5, 2025.
The VAI classification indicates that while the FDA has identified certain deficiencies or issues during the inspection, the company is not required to take immediate corrective action. Instead, the company is expected to voluntarily address the identified issues and implement corrective measures to ensure compliance with FDA regulations.
This inspection was a follow-up to a warning letter issued by the U.S. FDA to Zydus Lifesciences on August 29, 2024. The warning letter had highlighted certain deficiencies and violations of FDA regulations, and the recent inspection was conducted to assess the company’s progress in addressing these issues.
The fact that the FDA has issued an EIR with a VAI classification suggests that Zydus Lifesciences has made some progress in addressing the deficiencies identified in the warning letter. However, the company still needs to take further corrective action to ensure full compliance with FDA regulations.
The inspection and subsequent EIR are significant for Zydus Lifesciences, as they highlight the importance of maintaining high standards of quality and compliance in the pharmaceutical industry. The company must now take steps to address the identified issues and implement measures to prevent similar deficiencies from arising in the future.
Overall, the issuance of the EIR with a VAI classification is a positive step for Zydus Lifesciences, as it indicates that the company is on the path to resolving the issues identified by the FDA. However, the company must continue to work towards ensuring full compliance with FDA regulations to maintain its reputation and ensure the quality of its products.