Quality Control Concerns at Major U.S. Drug Manufacturing Plant

Thermo Fisher Scientific's Greenville plant, one of the largest contract drug manufacturing facilities in the U.S., has faced repeated regulatory issues over the past decade. Recent FDA inspections have identified concerns with the plant's manufacturing processes, including sterilization issues for a respiratory virus drug.

Thermo Fisher Scientific's Greenville plant, renowned as one of the largest U.S. contract drug manufacturing sites, has repeatedly failed to meet regulatory standards, according to U.S. Food and Drug Administration (FDA) documents obtained by Reuters. The most recent FDA inspection found holes in the production processes for Beyfortus, a medication designed to prevent respiratory syncytial virus in young children.

The FDA's findings were addressed and the issues resolved, as confirmed by both the FDA and Sanofi. The 1.7 million square foot facility produces a variety of critical medications, including hospital-administered drugs and weight-loss treatments. Despite no reported patient harm, the plant's inspection history raises questions about its quality control practices, prompting expert concern.

Notably, FDA inspections in May highlighted deficiencies in sterilization methods and equipment handling at the plant. While the facility has met regulatory requirements post-inspection, the recurring audits put Thermo Fisher under a spotlight, especially given its significant role in the pharmaceutical supply chain, valued at $8 billion of annual revenue.

(With inputs from agencies.)