Warning letter

CFS Dental, Inc: warning letter of Jan 16, 2013

FDA warning letter 391896 · Florida District Office

Key facts

Reference number 391896
Company CFS Dental, Inc
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jan 16, 2013
Posted date Jan 16, 2013
Issuing office Florida District Office
Product type Devices
CFR sections cited 803.17, 820, 803
Inspection city Hialeah
Inspection ZIP 33014
Inspection start date Dec 3, 2012
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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