The company said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.
Natco Pharma said the United States Food and Drug Administration (USFDA) has made six observations after the inspection of active pharmaceutical ingredient (API) facility in Mekaguda Village near Hyderabad. The regulator conducted the inspections at the Kothur facility during August 5-9, 2019.
“At the end of the inspection, the facility received six observations which are 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,” the company said in a regulatory filing. The company said it will provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.
It also said the 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.