US FDA issues six observations to Natco Pharma’s API facility near Hyderabad

Natco Pharma announced that the US health regulator has made six observations after the completion of inspection of active pharmaceutical ingredient (API) facility in Mekaguda Village, near Hyderabad.

The United States Food and Drug Administration (US FDA) conducted inspection at Kothur facility between August 5-9, 2019. “At the end of the inspection, the facility received six observations – mostly procedural in nature.

The company believes that none of observations are related to data integrity and that all the observations can be addressed within a short period of time,” Natco Pharma said in a regulatory filing. Natco Pharma said it will provide due justifications and corrective action plan within the next 15 working days to address the US FDA observations.

The company added that key points of the observations in Form 483 are the supplier and service provider agreements to be made more robust. Some procedural improvements in gowning section were recommended.

“Employees engaged in the manufacturing and packaging areas require more effective training. Procedural improvements needed in process revalidation protocols and approval of alternate supplier sources,” the company added.

Natco Pharma said visual stains were observed in some early stage reactors that need further diagnosis and improvement. ‘Status tags’ for certain drying process equipment were not to be found.