Thermo Fisher's plant making infant RSV drug breached FDA rules

 One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher Scientific over the past 10 years has repeatedly breached rules meant to ensure drugs are free of contamination, FDA documents show, including twice this year.

The most recent U.S. Food and Drug Administration inspection of Thermo Fisher's Greenville plant in May identified manufacturing issues for the respiratory syncytial virus drug Beyfortus, a preventive antibody therapy from AstraZeneca and Sanofi for infants and toddlers.

The issues were resolved to the FDA's satisfaction, the FDA and Sanofi said. There is no evidence that these manufacturing issues have resulted in harm to patients.

The 1.7 million square foot plant makes around 40 different medicines, according to the FDA's national drugs directory, including life saving hospital-administered and pharmacy drugs and Novo Nordisk's weight-loss medicine Wegovy. Thermo Fisher bought the plant in 2017 with its acquisition of contract manufacturer Patheon.

Growth in obesity medicines and complex biologic therapies is fueling demand for U.S. contract manufacturers like Thermo Fisher. But two manufacturing experts say the plant's 10-year audit record gives them reason to be concerned about the company's approach to quality control.

"There are multiple issues with the culture of the organization. They are not looking at the long term and have a fix-when-caught mentality versus a culture of prevention," said David Talmage, vice president of education at the Parenteral Drug Association, which provides training on best practices for sterile manufacturing.

The FDA's inspection of the Beyfortus production line found that required manufacturing processes fell short in areas such as ensuring some equipment was sufficiently sterilized, according to a report obtained by Reuters through a Freedom of Information Act (FOIA) request.

A spokesperson for Sanofi, which markets Beyfortus in the U.S. where it was approved last year, said the FDA's findings were all addressed and subsequently reviewed by the regulator. The FDA approved the Beyfortus doses before they left the plant for sale, the spokesperson said.

Sandy Pound, chief communications officer at Thermo Fisher, said the company participates in more than 1,000 regulator and customer inspections every year and takes regulator observations seriously. She did not comment on the specifics of the FDA audit.

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