Imaging manufacturer Guerbet faces financial challenges following recent FDA warning
Imaging manufacturer Guerbet is facing financial challenges following a recent safety warning from the U.S. Food and Drug Administration.
The France-based pharmaceutical firm operates a key plant in Raleigh, North Carolina, which makes imaging contrast agents such as MR product Elucirem (gadopiclenol). Back in October, regulators cited Guerbet for “significant violations” of good manufacturing regulations in the U.S.
Fast forward to today, and the infraction and related issues are dragging down the company’s financial results.
“Significant negative impact [is] expected from the situation in Raleigh on revenue, profitability, cash generation and group indebtedness…,” Guerbet said in a quarterly earnings report released March 11.
The original FDA inspection occurred between March and April of last year. In its warning letter, the agency cited several issues including sterility concerns for in-process drug samples. Authorities charge that Guerbet “failed to adequately investigate” these issues, with its subsequent risk assessments minimizing the potential impact on patients.
Following the inspection, the FDA made several demands including an independent investigation of Guerbet’s manufacturing operations and all potentially questionable drug batches.
“Correct any violations promptly,” Francis Godwin, director of the FDA’s Office of Manufacturing Quality, wrote Oct. 17. “Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other federal agencies from awarding contracts,” he added.
In its March earnings report, Guerbet said 2025 revenues for the Americas were down 4% year over year. The decline was concentrated in Q4, attributed to delays in the release of imaging agents produced by the North Carolina site. In its MRI division, revenues were down 2% due to a Q4 decrease in sales of Dotarem and Elucirem, prompted by the factory challenges.
Guerbet initiated its “remediation plan” in the fourth quarter and is continuing this work with a new management team and the support of outside experts. Corrective actions taken so far include modernizing equipment and processes with the aim of responding “as quickly as possible” to the FDA’s requests. Production slowdowns persist this month and “will continue to increase throughout the 2026 fiscal year,” Guerbet added. The Raleigh factory hopes to be ready for a follow-up FDA inspection by the end of fiscal 2026 and will return to a normal schedule by the end of this year.
Until then, Guerbet is anticipating “significant negative financial impact" from the situation. This will mainly affect commercial activity in both North and Latin America. The company said it expects profitability to be hampered by increased expenses relating to the FDA compliance plan, higher unit costs caused by the lower level of production, and “inventory destruction costs.” Free cash flow is expected to be negative in the near term, while net debt will increase. Guerbet reported a 2025 operating loss of $102.5 million (USD), driven in part by these challenges.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.