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Laurus Vizag unit gets 2 USFDA observations

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ET Health
09th November, 2019 07:51 IST
Hyderabad: City-based Laurus Labs on Friday said the US drug regulator, US Food & Drug Administration (USFDA) has completed inspection of its FDF and API integrated facility, Unit 2, at Visakhapatnam, with two observations.

The company said the two observations are procedural in nature and no data integrity issues were observed.

“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 a regulatory filing to the bourses.

The company said this was a product pre-approval audit by USFDA that was carried out from November 4 to 8, 2019.


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