United States Food and Drug Administration (USFDA) has conducted inspection at Unichem Laboratories’ Goa formulation facility from July 22 to July 31, 2019. The inspection was a routine GMP surveillance and Post Approval Inspection for the ANDAs submitted from this facility.
At the end of Inspection, the facility received 4 observations, with no repeat observations and are mostly procedural in nature.
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.