Ajanta Pharma’s Paithan Facility Receives Form-483 with Five Observations from USFDA
Ajanta Pharma’s Paithan Facility Receives Form-483 with Five Observations from USFDA
Key Highlights
The US FDA issued Form-483 with five observations to Ajanta Pharma after inspecting its Paithan manufacturing facility in Maharashtra from April 13–21, 2026.
Ajanta Pharma announced that the U.S. Food and Drug Administration (USFDA) has issued a Form-483 with five observations following an inspection of its manufacturing facility located in Paithan, Maharashtra.
The inspection, conducted from April 13–21, 2026, led to the identification of potential regulatory violations, which are documented in the Form-483.
Ajanta Pharma stated that it is preparing a response to the USFDA, which will be submitted within the stipulated timeframe. The company acknowledged that the Form-483 is issued when USFDA inspectors observe conditions that may constitute violations of regulatory standards.
