USFDA issues one observations of Unichem Ghaziabad formulations facility

Drug firm Unichem Laboratories on Monday said the US health regulator has issued one observation after the inspection of its formulations facility at Ghaziabad.

"The United States Food and Drug Administration (USFDA) conducted an inspection at the company's Ghaziabad formulation facility between August 19, 2019, to August 23, 2019. The inspection was a routine Good manufacturing practice (GMP) surveillance," Unichem said in a regulatory filing.

"At the end of the inspection, the facility received one observation which is not a repeat observation and is procedural in nature," the company added.

Unichem said it will provide the response and corrective action plan within the next 15 working days to address the USFDA observation.

Shares of Unichem Laboratories were trading 1.45 per cent lower at Rs 235.20 apiece on BSE.

-PTI

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