India, April 22 -- 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.

Published by HT Digital Content Services with permission from Dion Global Solutions Limited....