483
Zydus Lifesciences LimitedFDA 483 - Zydus Lifesciences Limited - June 18, 2025
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Zydus Lifesciences Limited in Matoda, Gujarat, India, a sterile drug product manufacturer, was cited with two observations during an FDA inspection. The inspection revealed significant deficiencies in the Quality Unit's procedures for investigating invalid laboratory results and a lack of adequate validation for aseptic process simulation studies, raising concerns about product sterility assurance.
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ID · 47a83472-6d58-4c2a-be9c-ef2902950f7a