form 483
UCB’s Swiss plant gets Form 483 from FDA over quality and records
Anika Sharma
UCB Farchim, a subsidiary of Belgian pharmaceutical company UCB, is facing regulatory scrutiny from the FDA. The FDA recently issued ...
Samsung BioLogics faces FDA scrutiny over data integrity and quality issues at Korean plant
Anika Sharma
The FDA recently issued manufacturing alerts, targeting high-flying companies Samsung Biologics and Nectar Lifesciences. For Samsung Biologics, a notable player ...
Novo Nordisk’s semaglutide facility in North Carolina faces FDA scrutiny over quality issues
Anika Sharma
Novo Nordisk’s shares faced a decline following reports that the FDA had raised concerns about manufacturing issues at the company’s ...