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FDA issues Form 483 with 6 observations on Natco's plant

Press Trust of India  |  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 andthat 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 effectivetraining, the FDA said in its observations.

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

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Mon, August 12 2019. 18:20 IST