USFDA flags five observations at Ajanta Pharma Paithan facility after inspection

Five observations could trigger tougher scrutiny and delays

Ajanta Pharma said the US FDA issued Form-483 with five observations following an inspection of its Paithan manufacturing facility in Maharashtra from April 13–21, 2026. The company said it will file its response within the required timeframe, adding that Form-483 is issued when inspectors identify potential regulatory violations that may need corrective action.