form 483

UCB’s Swiss plant faces FDA Form 483 | Pharma News

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 hit by FDA Form 483 over plant issues

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, semaglutide, fda, form 483, north carolina, quality issues, gmp violations

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 ...