FDC has received Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) for manufacturing facility located at, 19 & 20/2 Plot, MIDC Industrial Area, Dhatav, Roha, Raigad District, Maharashtra, India.
USFDA had conducted an inspection at said manufacturing facility from March 20, 2023 to March 24, 2023. FDA has determined that the inspection classification of this facility is ‘no action indicated’ (NAI). Based on this inspection, this facility is considered to be in an acceptable state of compliance with regards to current good manufacturing practice (CGMP).
FDC made a modest beginning with marketing of vitamins and a range of prescription formulations. The company subsequently set up their formulations manufacturing facility and also pioneered the manufacture of specialized ophthalmic formulations in India.
