Thermo Fisher Scientific (TMO), a leading player in the pharmaceutical industry, is facing scrutiny despite its promising position in the growing injectables market. The company’s Greenville facility, one of the largest contract drug manufacturing sites in the US, has been repeatedly flagged for regulatory violations by the Food and Drug Administration (FDA).
While the FDA has acknowledged and addressed the issues, concerns linger about the plant’s commitment to quality control. These concerns arise from a history of contamination prevention issues, including two incidents earlier this year.
The Greenville facility manufactures a wide range of medications, including Novo Nordisk’s (NVO) popular weight-loss drug Wegovy. Recently, analysts have highlighted Thermo Fisher’s strong position in the contract development and manufacturing organization (CDMO) sector, particularly in the injectables space. The company is poised to benefit from the increasing demand for GLP-1 drugs and the growing biologics market.
However, the plant’s recent struggles with quality control have raised questions about its ability to maintain a consistent level of manufacturing excellence. A May inspection by the FDA revealed 17 deficiencies during the production of Sanofi and AstraZeneca’s Beyfortus, a respiratory syncytial virus (RSV) preventive drug for infants. The FDA identified issues with visual inspections, staff handling of sterile components, and equipment sterilization procedures.
Despite addressing these issues and providing the FDA with data on drug safety, experts remain concerned about the plant’s long-term approach to quality control. This concern is amplified by the fact that the facility manufactures crucial medications like Wegovy and Beyfortus.
While Thermo Fisher’s Greenville facility may be well-positioned to capitalize on growth in the injectables market, addressing these quality control concerns is essential to maintaining its reputation and ensuring patient safety.
