Warning letter

Owen Mumford USA, Inc.: warning letter of Jun 4, 2014

FDA warning letter 423170 · Atlanta District Office

Key facts

Reference number 423170
Company Owen Mumford USA, Inc.
Subject Medical Device Reporting/Misbranded
Issue date Jun 4, 2014
Posted date Jun 24, 2014
Issuing office Atlanta District Office
Product type Devices
CFR sections cited 803, 803.3, 803.17, 803.50(a), 803.50(b)
Inspection city Marietta
Inspection ZIP 30062
Inspection start date Dec 3, 2013
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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