The Quality Lowdown: US FDA Warning Letters, 483 Reports Hit Poor Sterility And Lax Investigations
Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.
You may also be interested in...
Warning letters examined in part five of our in-depth report showed how prescription drug firms got into trouble with the US FDA in 2022 by conducting investigations that were too narrow and that failed to trigger appropriate corrective actions. Several firms failed in their sterile injectables contamination investigations. Other inquiries failed to establish proper control of tablet and capsule manufacturing.
Bristol Myers Squibb has launched three new first-in-class drugs this year – Opdualag, Camzyos and Sotyktu – and investors are closely watching the early momentum.
A complex transformation is underway as client proposes to acquire CDMO facilities that vaccinated the world against the COVID-19 pandemic for pivot to the obesity epidemic.