The formulation facility of Natco Pharma in Kothur village, near Hyderabad, has received a single observation at the end of a pre-approval inspection from the United States Food and Drug Administration (USFDA).
The inspection was conducted from March 2 to 6. “At the end of the inspection, the facility received a single observation related to equipment qualification of a co-mill used in the process that had operating speed slightly outside the qualification range.
The company believes that this is a minor observation and can be addressed within a short period of time,” a release from the Hyderabad-headquartered drug-maker said.
The company said it would provide due justification and corrective action plan within next 15 working days to address the observation.