Ajanta Pharma on Wednesday said the US Food and Drug Administration has issued a Form 483 with five observations for its manufacturing facility in Paithan, Maharashtra.
The observations follow an inspection conducted between April 13 and April 21, 2026. The company, in a regulatory filing, stated that the inspection concluded with the issuance of the Form 483.
Ajanta Pharma added that it will submit its response to the regulator within the prescribed timeline.