U.S. FDA Flags Quality, Procedural Lapses At Biocon Biologics’ Facilities

Photo Credit: <strong>Image Source:&nbsp;Biocon&nbsp;(Website)</strong> The U.S. FDA issued Form 483s with 11 observations each for the two sites in Bengaluru and six for the Malaysia site. Vishal Marathe Updated On 05:02 PM IST, 27 Sep 2022

Photo Credit: Image Source: Biocon (Website) Photo Credit: The FDA issued 11 observations each for the two sites in Bengaluru and six for the Malaysian site. Photo Credit: The inspections were triggered for three pre-approval inspections for a biosimilar for cancer of kidney, lung or breast; a diabetes drug; and for capacity expansion of a biosimilar for stomach cancer. [{ "selector": ".story-desp_p", "duration": "1.2s", "easing": "ease-in-out", "keyframes": [{ "opacity": 0 }, { "opacity": 1 }, { "opacity": 1 } ] }, { "selector": ".substory_h1", "duration": "0.75s", "easing": "linear", "keyframes": [{ "transform": "translateY(40px)", "opacity": 0 }, { "transform": "translateY(0px)", "opacity": 1 }, { "transform": "translateX(0)", "opacity": 1 } ] } ]

U.S. FDA Flags Quality, Procedural Lapses At Biocon Biologics’ Facilities

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