Thermo Fisher's Manufacturing Plant Faces FDA Scrutiny

Thermo Fisher's U.S. drug manufacturing plant has faced repeated FDA inspections due to contamination concerns, including issues with a vital respiratory medicine. Despite resolving the recent issues, experts worry about the company's quality control approach. The plant's operational challenges have raised broader questions about production standards in the industry.

Thermo Fisher Scientific's Greenville plant, one of the largest U.S. drug manufacturing facilities, has faced repeated scrutiny from the FDA over contamination concerns, according to official documents.

In May, the FDA identified manufacturing issues with Beyfortus, a preventive antibody therapy for children, but later deemed the issues resolved. No patient harm was reported.

Experts remain cautious about Thermo Fisher's long-term quality control culture, as frequent audits highlight ongoing concerns. Despite this, the company's contract manufacturing segment remains a key growth driver, bolstered by demand for biologic therapies.

(With inputs from agencies.)