By: IPP Bureau
Last updated : June 16, 2023 10:15 am
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
Bliss GVS Pharma Limited had earlier announced that the United States Food and Drug Administration (US FDA) conducted a Pre-Approval Inspection (PAI) and Good Manufacturing Practice (GMP) at the company's manufacturing unit in Palghar, Maharashtra.
Pursuant to above inspection by the United States Food and Drug Administration (US FDA), the company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection through which the US FDA agency assigned the inspection classification of the facility as "Voluntary Action Indicated (VAI)".
Based on this inspection and the US FDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP).