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FDA Rebukes Zydus Injectables Facility For Glass Contamination, Aseptic Oversight

Warning Letter Against Indian Plant In Vadodara Follows April Inspection

 
• By Dean Rudge

Zydus Lifesciences must provide the US Food and Drug Administration with a detailed action plan addressing specific violations of current good manufacturing practice at its injectables site in Vadodara, Gujarat.

Warning Letter
• Source: Shutterstock

Failure to thoroughly investigate unexplained batch discrepancies or failures and negligence in establishing and following appropriate written procedures that are designed to prevent microbiological contamination have been detailed in a US Food and Drug Administration warning letter sent to Zydus Lifesciences’ injectables facility in Vadodara, Gujarat, India.

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