Inspection Issues at Thermo Fisher’s Greenville Plant

By Patrick Wingrove

(Reuters) – One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific (NYSE:TMO) has repeatedly breached rules designed to ensure drug safety, according to FDA documents, including twice this year.

The latest inspection by the U.S. Food and Drug Administration (FDA) at Thermo Fisher’s Greenville plant in May highlighted manufacturing problems concerning Beyfortus, a preventive antibody therapy for respiratory syncytial virus produced for infants and toddlers by AstraZeneca (NASDAQ:AZN) and Sanofi (NASDAQ:SNY).

Although issues were addressed to the FDA’s satisfaction, there is no evidence indicating harm to patients as a result of these problems.

The 1.7 million square foot facility produces roughly 40 different medicines, including life-saving drugs and Novo Nordisk (NYSE:NVO)’s weight-loss medication Wegovy. Thermo Fisher acquired this plant in 2017 through its purchase of contract manufacturer Patheon.

The demand for obesity medications and complex biologic therapies is expected to drive growth for U.S. contract manufacturers like Thermo Fisher. However, two manufacturing experts expressed concerns about the plant’s ten-year audit history, citing a culture that prioritizes short-term fixes over quality control and prevention.

David Talmage, vice president of education at the Parenteral Drug Association, stated, “There are multiple issues with the culture of the organization… a fix-when-caught mentality versus a culture of prevention.”

The recent FDA audit pointed out that required processes were inadequate, particularly in maintaining sterile equipment used in manufacturing. A Sanofi spokesperson confirmed that all FDA findings were addressed and reviewed before Beyfortus was sold.

Sandy Pound, chief communications officer at Thermo Fisher, noted the company engages in over 1,000 regulatory and customer inspections annually and takes all regulatory observations seriously.

FDA Findings

The FDA report indicated 17 shortcomings during the Beyfortus audit, including insufficient visual inspections of injectable drugs and protocol issues related to sterile component handling. One notable failure involved the lack of studies supporting how bubble size thresholds in injectable medications were determined.

Such bubbles can pose serious risks like fatal blood blockages. While the FDA did not take any regulatory action this time, it emphasized that usual concerns are resolved collaboratively with companies, contingent on their willingness to comply quickly.

Experts reviewed the documents and expressed alarm regarding the failure to follow procedures preventing microbial contamination, which highlighted troubling lapses in sterilization routines.

The FDA’s earlier inspection in February targeted vaccine production, where it noted concerns in quality controls for COVID and flu vaccines manufactured at the facility. However, neither Moderna nor CSL, both vaccine producers, operated there during FDA visits.

Thermo Fisher’s Greenville plant received $49 million from the U.S. Department of Defense in 2020 to aid in COVID vaccine production, becoming the latest government-supported factory to fall below FDA standards.

Thermo Fisher’s manufacturing division, operating as Patheon and comprising over 60 plants across 24 countries, generates around $8 billion, representing 19% of its total $42.8 billion annual revenue.

Analyst Justin Bowers from Deutsche Bank suggests that contract manufacturing should continue to propel Thermo Fisher’s growth due to sustained market demand.