FDA warns Zydus Lifesciences over significant manufacturing violations at its Gujarat plant.

The FDA has warned Zydus Lifesciences over manufacturing issues at its Gujarat plant, citing significant violations of good manufacturing practices. An inspection revealed the company's failure to investigate drug contamination and prevent microbiological risks. The FDA requires a detailed remediation plan to address these issues, warning that new drug application approvals may be withheld until compliance is achieved.

September 15, 2024
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