Thermo Fisher's Greenville Plant Cited for FDA Rule Breaches

Repeated violations at the drug manufacturing facility raise quality control concerns, though no patient harm has been reported.

• The FDA identified manufacturing issues at Thermo Fisher's Greenville plant during inspections in February and May 2024.
• These issues pertained to the production of Beyfortus, an RSV preventive therapy for infants, by AstraZeneca and Sanofi.
• Despite the breaches, the FDA and Sanofi confirmed that all concerns were resolved satisfactorily, with no evidence of patient harm.
• Experts have criticized the plant's long-term quality control culture, highlighting a 'fix-when-caught' mentality.
• The Greenville facility, acquired by Thermo Fisher in 2017, is critical to the company's $8 billion manufacturing business.

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