Dexcom receives warning letter concerning 2 manufacturing plants.
Dexcom's recent financial filings revealed that they had received a warning letter from the FDA following inspections at its facilities in Mesa, Arizona (in June 2024) and San Diego (in October and November 2024).
After this news was released, Dexcom said they remained confident to resolve the issues, however, on 26 March the FDA released further details which are much more illuminating.
The FDA revealed that there were quality control issues with Dexcom’s G6 and G7 CGMs and that they had raised concerns with a design change which meant that sensors were less accurate! And this could potentially “cause higher risks for users who rely on the sensors to dose insulin or make other diabetes treatment decisions”.
The change involved a component used in the resistance layer of Dexcom’s sensors previously sourced from an external supplier which Dexcom had sought to bring in-house. The process related to the coating of the sensor filament using a different chemical compound, without FDA approval, meaning that Dexcom’s devices were misbranded.
It's understood that Dexcom has ceased distribution of G7 sensors with the inferior component and reverted back to the external supplier, but the company’s response did not address affected G6 sensors. Dexcom's Chief Operating Officer, Jake Leach, recently stated that there is no need to recall any sensors.
According to analysts, the company has already made process improvements and introduced new controls about three months ago. Dexcom’s management also doesn’t expect this to delay the FDA’s review of its 15-day sensor.
Financially, Dexcom believes the warning letter won’t significantly affect its manufacturing capacity or 2025 financial targets. Analysts at Leerink Partners agree, saying Dexcom isn’t anticipating any big extra costs related to resolving the warning. However, Dexcom did acknowledge that the FDA could take further action if the issues aren’t resolved to their satisfaction.
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