Thermo Fisher's Plant Under Scrutiny Amid FDA Concerns

Thermo Fisher's Greenville plant, a major contract drug manufacturer in the U.S., has faced repeated FDA scrutiny for contamination risks. Recent audits identified issues in the production of Beyfortus, a preventive antibody therapy. Concerns exist over quality control, but no patient harm has been reported.

Thermo Fisher's Greenville plant, one of the largest contract drug manufacturing facilities in the U.S., has come under scrutiny following multiple FDA inspections citing contamination risks, according to agency documents. Despite recent infractions involving the production of Beyfortus, a preventive therapy for infants, the FDA, alongside Sanofi, affirmed the issues were rectified without evidence of patient harm.

The plant, acquired by Thermo Fisher in 2017, produces around 40 drugs, including Novo Nordisk's key obesity medicine, Wegovy. However, experts express concern over the company's long-standing audit record, suggesting a culture that addresses issues only when discovered rather than preventative measures.

David Talmage from the Parenteral Drug Association criticized the plant's quality control practices while Steven Lynn, a former FDA compliance head, highlighted inadequate checks for bubbles in injectables as worrying. Thermo Fisher's commitment to regulatory responses is noted, yet the need for improved preventive strategies remains critical.

(With inputs from agencies.)