Warning letter

ThyssenKrupp Access Corp. [ARCHIVED]: warning letter of Aug 23, 2011

FDA warning letter 177872 · Kansas City District Office

Key facts

Reference number 177872
Company ThyssenKrupp Access Corp. [ARCHIVED]
Subject Premarket Approval/Misbranded/Adulterated
Issue date Aug 23, 2011
Posted date Aug 23, 2011
Issuing office Kansas City District Office
Product type Devices
CFR sections cited 803.50(a)(2), 803, 803.17, 820
Inspection city Grandview
Inspection ZIP 64030
Inspection start date Feb 24, 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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