India's biotech major Biocon Limited today said FDA of United States has audited its aseptic drug product facility here and issued an Establishment Inspection Report (EIR) in relation to the current Good Manufacturing Practice.
"Biocon confirms that the US Food and Drug Administration (FDA) has issued an Establishment Inspection Report (EIR) in relation to the cGMP (current Good Manufacturing Practice) inspection of its aseptic drug product facility that was audited between May 25 and June 3, 2017," a company spokesperson said in a statement here.
The company also stated that the FDA has classified the outcome of the inspection as Voluntary Action Indicated.
It further said states that the inspection is closed.
Biocon since 1978 has evolved from an enzyme-manufacturing company into a fully integrated biopharmaceutical enterprise.
Today, it leverages a formidable combination of proprietary fermentation technologies and research skills to develop affordable therapy for unmet medical needs.
Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw.
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