The United States Food and Drug Administration (USFDA) has conducted inspection at the Unichem Laboratories’ Ghaziabad formulation facility between August 19, 2019 to August 23, 2019. The inspection was a routine GMP surveillance. At the end of inspection, the facility received 1 observation which is not a repeat observation and is procedural in nature.
The company will provide the response and corrective action plan within next 15 working days to address the USFDA observation.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.