The company will provide response, corrective action plan within next 15 working days
Unichem Laboratories 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 (US FDA) conducted 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 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 next 15 working days to address the US FDA observation.