Warning letter

DiamoDent: warning letter of Jan 5, 2016

FDA warning letter 474517 · Los Angeles District Office

Key facts

Reference number 474517
Company DiamoDent
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jan 5, 2016
Posted date Jan 5, 2016
Issuing office Los Angeles District Office
Product type Devices
CFR sections cited 820, 807.81(b)
Inspection city Dana Point
Inspection ZIP 92624
Inspection start date Jun 17, 2015
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • VAI 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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