USFDA completes inspection of Natco's Kothur facility

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.

Mar 09, 2020 03:03 IST India Infoline News Service

natco pharma
Natco Pharma on Friday announced the completion of a Pre-Approval inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur Village, near Hyderabad, India, which was conducted from March 2-6, 2020.

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.

The company will provide due justification and corrective action plan within the next 15 working days to address this observation.

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