After the inspection of its Visakhapatnam facility in Andhra Pradesh, the US health regulator made two observations, reported Drug firm Laurus Labs on Friday. There were no data integrity issues observed in this inspection.
The Laurus Labs said in a filing to the BSE, that it has completed the United States Food and Drug Administration (USFDA) inspection of its active pharmaceutical ingredient (API) facilities in Units 1 and 3 at Parawada, Visakhapatnam, with two procedural observations. “This is a regular surveillance audit by USFDA, and no data integrity issues were observed in the inspection,” Laurus Labs said. However, the
details of the observations made by the regulator were not disclosed by the company.