US body finds fault with Natco Pharma
The observations are related to complaint and incident investigations, stability backlog and procedural SOPs.
Hyderabad: City-based drug firm Natco Pharma on Wednesday revealed that the US drug regulator has found some lapses in quality control measures at its formulation plant at Kothur in Telangana.
“The responsibilities and procedures applicable to the quality control unit are not fully followed. The written stability testing programme is not followed,” US Food and Drug Administrator said in its inspection report.
The FDA had inspected the Kothur facility between January 16-24. Reacting to the observations, Natco Pharma said that all observations are minor in nature and are “correctable and procedural.
“The observations are related to complaint and incident investigations, stability backlog and procedural SOPs.” Natco said it will provide due justifications and corrective action plan within next 15 days to the address the FDA observations.