---
schema_version: "secwatch.filing_event.v1"
accession: "0001093557-25-000047"
form_type: "8-K"
ticker: "DXCM"
cik: "0001093557"
company_name: "DEXCOM INC"
filed_at: "2025-03-07T23:59:59+00:00"
generated_at: "2026-05-25T02:55:54.611306+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001093557-25-000047
- form_type: 8-K
- ticker: DXCM
- cik: 0001093557
- company_name: DEXCOM INC
- filed_at: 2025-03-07T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1093557/000109355725000047/0001093557-25-000047-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1093557/000109355725000047/dxcm-20250304.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001093557-25-000047
- JSON: https://secwatch.observer/filing/0001093557-25-000047.json
- Plain text: https://secwatch.observer/filing/0001093557-25-000047.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.