NEW DELHI, Jan 25: Natco Pharma today said the US health regulator has made six observations after the completion of inspection of its Kothur formulation facility in Telangana.
The United States Food and Drug Administration (USFDA) had inspected the Kothur formulation facility between January 16-24, 2017, Natco Pharma said in a BSE filing.
The company, however, added that all observations are correctable and procedural and it believes are minor in nature.
“The observations are related to complaint and incident investigations, stability backlog and procedural SOPs,” it said.
Natco Pharma said it will provide due justifications and corrective action plan within next 15 working days to the address the USFDA observations.
In August last year, the drug firm had received Establishment Inspection Report (EIR) for the same facility from the US health regulator after successful completion of inspection.
EIR is given to an establishment after the completion of the inspection by the USFDA.