Thermo Fisher Scientific’s (NYSE:TMO) one of the largest contract drug manufacturing sites in the U.S., has repeatedly been flagged for regulatory violations.

Thermo Fisher’s Greenville facility manufactures around 40 medicines, including Novo Nordisk A/S’ (NYSE:NVO) weight-loss drug Wegovy (semaglutide).

Over the past decade, the Greenville plant has been cited for issues related to contamination prevention, including two incidents earlier this year, Reuters noted, citing FDA documents.

Also Read: Thermo Fisher Q2 Earnings: Marginal Revenue Dip, Completes Olink Acquisition, Lifts Annual Profit Outlook.

Despite these concerns, the FDA did not take regulatory action, stating that the issues had been resolved to its satisfaction and that there was no evidence that patients had been harmed as a result.

The Reuters report highlighted that the FDA identified 17 deficiencies during the Beyfortus audit, including insufficient visual inspections for particulate matter in injectable drugs and issues with staff handling of sterile components.

The agency noted that Thermo Fisher’s equipment sterilization procedures were inadequate, and visual inspections for injectable drug contaminants failed.

Thermo Fisher has since addressed these issues, providing the FDA with the necessary data on drug safety, including control over bubble size in injectable medications. However, experts remain concerned about the plant’s approach to quality control.

Price Action: TMO stock is down 0.39% at $598.59 during the premarket session at last check Friday.

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