Natco Pharma announced the completion of a regulatory inspection from the United States Food and Drug Administration (USFDA) for its Formulation facility in Kothur Village, near Hyderabad, India, which was conducted during the period 30 May, 2019 to 5 June, 2019.
At the end of the inspection, the facility received nine observations, with no repeat observations and mostly procedural in nature. The company believes that none of observations are related to data integrity and that all of the observations can be addressed within a short period of time.
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