Biocon stated that it has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the post approval and GMP inspection of its small molecules API manufacturing facility at Biocon Campus, Bengaluru, conducted between February 20 and February 26, 2020.
“The EIR has been closed with a “VAI” classification for the observations. At the conclusion of the inspection last month, the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the company,” Biocon said in a press release.
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“We remain committed to global standards of quality and compliance,” the company added. Biocon Limited is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune.