USFDA issues Form-483 with 5 observations to Ajanta Pharma's Paithan facility

Ajanta Pharma said the US FDA has issued Form-483 with five observations after inspecting its Paithan manufacturing facility in Maharashtra from April 13–21, 2026. The company stated it will respond within the stipulated timeframe, while noting that Form-483 is issued when inspectors observe potential regulatory violations.

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