Natco Pharma has received Form 483 observations for two of its facilities after a recent United States Food & Drug Administration (USFDA) inspection. However, the company says there is no adverse impact on its future pipeline.
In a statement, the company updated that an inspection was conducted by the USFDA in two of its manufacturing facilities recently the active pharmaceutical ingredients (API) manufacturing facility at Manali, near Chennai and the pharmaceutical formulations facility at Kothur, near Hyderabad, during early February and March, 2016, respectively.
“We have received 483 observations for both facilities and believes them to be of minor in nature,” the company said. The company has already sent response and compliance report for these observations.