Warning letter

G3 Medical [ARCHIVED]: warning letter of Oct 13, 2009

FDA warning letter 80284 · Atlanta District Office

Key facts

Reference number 80284
Company G3 Medical [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Oct 13, 2009
Posted date Oct 13, 2009
Issuing office Atlanta District Office
Product type Devices
CFR sections cited 820
Inspection city Asheville
Inspection ZIP 28803
Inspection start date Aug 3, 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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