Laurus Labs gets 2 USFDA observations

Laurus Labs Limited, a leading research and development driven pharmaceutical company in India, has completed the US Food and Drug Administration (USFDA) inspection of its Unit – 2 (FDF&API integrated facility), located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh, with two observations which are procedural in nature.

This is a product pre-approval audit by USFDA, and no data integrity issues were observed in the inspection.

“The company is pleased to announce that the USFDA inspection of its FDF & API Integrated Facility, Unit 2, at Visakhapatnam has been completed with two observations which are procedural in nature. This is a product pre-approval audit by USFDA, and no data integrity issues were observed in the inspection,” Laurus Labs said in satement.

The inspection was carried out from 04 November, 2019 – 08 November, 2019.