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).
Despite the warning, Dexcom is confident it can resolve the issues without disrupting its business. 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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