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 also noted that annual product reviews of one of the products were not approved in time by the company.
Among other observations the inspection team noted that the standard operating procedure (SOP) on manual interpretation of impurity peaks was made effective in November 2018, but the interpretation of impurity peaks performed prior to November 2018 were not reviewed for appropriateness and accuracy
The company said it will provide due justifications and corrective action plan within the next fifteen days to address the US FDA observations.