Unichem Labs gets 4 USFDA observations for Goa formulation facility
At the end of an inspection, the facility received four observations, with no repeat observations and are mostly procedural in nature, Unichem Labs said in a filing with BSE.
Mumbai: Pharma major Unichem Laboratories said that the United States Food and Drug Administration (USFDA) conducted an inspection at company's Goa formulation facility between 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 an inspection, the facility received four observations, with no repeat observations and are mostly procedural in nature, the company said in a filing with BSE.
Unichem will provide the responses and corrective action plan within the next 15 working days to address the USFDA observations.
Founded in 1944 by Padmabhushan Amrut V Mody, Unichem Labs is currently active in Finished Formulations, APIs, Contract Manufacturing, Custom Synthesis etc. Their RnD Site at Goa has expertise in product development, process chemistry and developing complex APIs for the global market.