FDA officials inspected the Natco’s facility in Mekaguda village between August 5 and 9. (Photo: Reuters)
FDA officials inspected the Natco’s facility in Mekaguda village between August 5 and 9. (Photo: Reuters)

Natco gets six USFDA observations for its Mekaguda plant

  • FDA finds procedural and handling gaps in settling plate management in the microbiology and lab employees engaged in the manufacturing and packaging areas require more effective training
  • Natco to provide due justifications and corrective action plan within the next 15 working days to address the FDA observations

HYDERABAD : Natco Pharma Limited on Monday said it has received Form 483 with six observations from the US Food and Drug Administration on the active pharmaceutical ingredient (API) facility of the company in Mekaguda village, near here.

FDA officials inspected the facility between August 5 and 9, a press release from Natco said.

"At the end of the inspection, the facility received six observations mostly procedural innature. The company believes that none of the observations are related to data integrity and that all the observations can be addressed within a short period of time," the release said.

Procedural and handling gaps found in settling plate management in the microbiology andlab employees engaged in the manufacturing and packaging areas require more effective training, the FDA said in its observations.

The company would provide due justifications and corrective action plan within the next 15 working days to address the FDA observations, it added.

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