Warning letter

Xanacare Technologies, LLC: warning letter of Oct 28, 2014

FDA warning letter 439240 · Denver District Office

Key facts

Reference number 439240
Company Xanacare Technologies, LLC
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Oct 28, 2014
Posted date Nov 4, 2014
Issuing office Denver District Office
Product type Devices
CFR sections cited 807.81(b), 807.81(a)(3)(i), 820
Inspection city Denver
Inspection ZIP 80237
Inspection start date Jul 31, 2014
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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