Laurus Labs gets 3 observations from USFDA for Visakhapatnam facility

Drug firm Laurus Labs on Thursday said US health regulator has made three observations after completing inspection of its Visakhapatnam facility in Andhra Pradesh. The company has completed the pre approval inspection (PAI) for an active pharmaceutical ingredient (API) manufactured at its Units 1&3, located at Visakhapatnam by the United States Food and Drug Administration, Laurus Labs said in a filing to the BSE.

The inspection was completed with three observations, 'which are procedural in nature'. No data integrity issues were observed in the inspection, it added. The company, however, did not provide any details about the observations.

The inspection was carried out from November 18 – 21, 2019, it added. Shares of Laurus Labs closed at Rs 332.15 per scrip on the BSE, down 2.11 per cent from its previous close.

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