Warning letter

Erchonia Corporation [ARCHIVED]: warning letter of Jan 21, 2011

FDA warning letter 92484 · Dallas District Office

Key facts

Reference number 92484
Company Erchonia Corporation [ARCHIVED]
Subject Premarket Approval/Misbranded/Adulterated
Issue date Jan 21, 2011
Posted date Jan 21, 2011
Issuing office Dallas District Office
Product type Devices
CFR sections cited 807.81, 820, 807.81(a)
Inspection city Fountain Inn
Inspection ZIP 29644
Inspection start date Nov 17, 2009
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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