Warning letter

ThyssenKrupp Access Manufacturing, LLC: warning letter of Mar 27, 2012

FDA warning letter 271496 · Chicago District Office

Key facts

Reference number 271496
Company ThyssenKrupp Access Manufacturing, LLC
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Mar 27, 2012
Posted date Mar 27, 2012
Issuing office Chicago District Office
Product type Devices
CFR sections cited 820
Inspection city Roanoke
Inspection ZIP 61561
Inspection start date Nov 8, 2011
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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