Thermo Fisher Plant Producing Infant RSV Drug Violated FDA Regulations – Reuters

One of the largest contract drug manufacturing facilities in the United States, owned by Thermo Fisher Scientific, has frequently violated regulations meant to ensure medication safety, according to a report.

Documents from the U.S. Food and Drug Administration revealed that a recent inspection of Thermo Fisher’s Greenville facility uncovered problems related to the production of Beyfortus, a treatment for respiratory syncytial virus designed for infants and toddlers. This therapy is a collaboration between Sanofi and AstraZeneca.

The FDA inspection report indicated that the manufacturing processes at the facility particularly failed to ensure adequate sterilization of equipment. Overall, the audit identified 17 issues concerning the production of Beyfortus, including insufficient visual inspections for particulate matter in injectable medications and a lack of studies validating how Thermo Fisher determined acceptable thresholds for bubbles that can form in injections. Such bubbles may lead to potentially fatal blockages in veins and arteries.

Both the FDA and Sanofi, which markets Beyfortus in the U.S., stated that the concerns had been adequately addressed to meet federal standards. Additionally, the report noted that there was no evidence suggesting that these manufacturing issues had harmed any patients.

The FDA clarified that it had not pursued or recommended any regulatory or enforcement actions following its audit, deeming that such measures were unnecessary at this time. The agency emphasized that the facility had sufficiently resolved several concerns, including the safe management of bubble size.

A representative from Sanofi also indicated that the FDA approved Beyfortus doses before they were shipped for sale. Meanwhile, a spokesperson for Thermo Fisher highlighted that the company undergoes more than 1,000 regulatory inspections annually and takes regulatory feedback seriously.

Shares of Thermo Fisher experienced a slight decline in premarket trading.