Natco Pharma gets 9 observations from US drugs regulator for Kothur plant

The Food and Drug Administration's observations were procedural and "can be addressed within a short period of time", says Natco.

Natco Pharma Thursday said USA’s drugs regulator had made nine observations about its formulation facility in Kothur, Telangana, after inspections between May 30 and June 5.

The Food and Drug Administration's (FDA) observations were procedural and “can be addressed within a short period of time”, said Natco in a statement.

One observation was that the field alert report (FAR) was not submitted within three days of receipt of information of failure of distributed batches to meet specifications. Out of trend results of a distributed batch were not extrapolated to obtain expected impurity value at the end of shelf life. The inspection team