FDA issues 9 observations to Natco's Kothur unit

Hyderabad: Natco Pharma Limited on Thursday said the US Food and Drug Administration has issued nine observations under Form 483 for its formulation facility in Kothur Village, near here. The city-based drug-maker said, the inspection was conducted between May 30 and June 5 and the company would provide due justifications and corrective action plan within the next 15 working days to address the USFDA observations.

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 the observations were related to data integrity and that all of the observations can be addressed within a short period of time, it said. Visual inspection of products carried out as part of investigation was not properly documented, the FDA said in one of the observations.