October 4, 2024 9:35 PM

Thermo Fisher’s plant making infant RSV drug breached FDA rules, documents show

One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are free of contamination, FDA documents show, including twice this year. The most recent U.S. Food and Drug Administration inspection of Thermo Fisher's Greenville plant in May identified manufacturing issues for the respiratory syncytial virus drug Beyfortus, a preventive antibody therapy from AstraZeneca and Sanofi for ...