USFDA had conducted a pre-approval inspection of Biocon's subsidiary Biocon Sdn BHd's manufacturing facility in Malaysia for Insulin Glargine between February 10 and 21. "At the conclusion of the inspection, the agency issued a Form 483 with three observations which we believe are procedural in nature," a Biocon spokesperson said in a regulatory filing.from Healthcare/Biotech-Industry-Economic Times https://ift.tt/2T8ziGS
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