Warning letter

Richard Wolf Medical Instruments Corp.: warning letter of Feb 28, 2014

FDA warning letter 407796 · Chicago District Office

Key facts

Reference number 407796
Company Richard Wolf Medical Instruments Corp.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Feb 28, 2014
Posted date Apr 22, 2014
Issuing office Chicago District Office
Product type Devices
CFR sections cited 820
Inspection city Vernon Hills
Inspection ZIP 60061
Inspection start date Mar 25, 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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