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.
FDA Rebukes Zydus Injectables Facility For Glass Contamination, Aseptic Oversight
Warning Letter Against Indian Plant In Vadodara Follows April Inspection
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.
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