Warning letter

Dexcom Inc [ARCHIVED]: warning letter of May 21, 2010

FDA warning letter 96247 · Los Angeles District Office

Key facts

Reference number 96247
Company Dexcom Inc [ARCHIVED]
Subject Medical Device Reporting/Misbranded
Issue date May 21, 2010
Posted date May 21, 2010
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 803, 803.50(a)(2)
Inspection city San Diego
Inspection ZIP 92121
Inspection start date Jan 11, 2010
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA warning letters

FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date:

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