Warning letter

Ideal Optics, Inc.: warning letter of Sep 28, 2004

FDA warning letter UCM146617 · Atlanta District Office

Key facts

Reference number UCM146617
Company Ideal Optics, Inc.
Subject Quality System Regulation for Medical Devices/Adulterated
Issue date Sep 28, 2004
Posted date Sep 28, 2004
Issuing office Atlanta District Office
Product type Devices
CFR sections cited 820, 820.5
Country 3
Inspection city Duluth
Inspection ZIP 30097-4933
Inspection start date Aug 4, 2004
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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