The consent decree is an agreement between FDA and the pharma company that usually bars the latter from manufacturing and distribution until it can prove, through a TPC, that it has achieved and can maintain regulatory compliance. In response to specific queries of The Indian Express, the Biocon spokesperson stated: "Biocon, in its statement to stock exchange on November 20, 2017, has confirmed that the USFDA has issued an Establishment Inspection Report (EIR) in relation to the CGMP inspection of its aseptic drug product facility that was audited between May 25 and June 3. The USFDA has classified the outcome of this inspection as VAI ("voluntary action indicated") and the EIR states that the inspection is closed"