Natco Pharma announced on Thursday that the U.S. Food and Drug Administration (USFDA) has issued a Form 483 with seven observations following an inspection of its pharma division in Kothur, Hyderabad.

According to a regulatory filing, the inspection was conducted from June 9 to June 19, 2025.

"Upon completion of the inspection, the company received seven observations in the Form 483," Natco Pharma stated.