FDA 483 - Shashi Phytochemical Industries - June 19, 2026
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An FDA inspection of Shashi Phytochemical Industries in Alwar, India, an API manufacturer, revealed a significant deficiency in their quality control processes. The firm failed to perform appropriate laboratory determination for the identity and strength of active ingredients in drug products prior to release and for stability testing. This included not conducting required HPLC identification and LC content testing for API batches shipped to the US, as per the current USP monograph.
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