DexCom receives FDA warning letter for manufacturing deficiencies; reaffirms FY2025 revenue guidance

DEXCOM INC

FDA warning letter cites non-conformities in manufacturing processes and quality systems at San Diego and Mesa facilities.
Inspections occurred Oct–Nov 2024 (San Diego) and June 2024 (Mesa); company had submitted Form 483 responses.
Warning letter does not restrict production, distribution, or 510(k) clearance; no recall required.
DexCom expects no material impact on manufacturing capacity or FY2025 revenue guidance issued Feb 13, 2025.
Company is preparing written response and intends corrective actions; resolution timeline uncertain.

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