Warning letter

Gulf Medical Fiberoptics, Inc. [ARCHIVED]: warning letter of Jul 27, 2011

FDA warning letter 195372 · Florida District Office

Key facts

Reference number 195372
Company Gulf Medical Fiberoptics, Inc. [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date Jul 27, 2011
Posted date Jul 27, 2011
Issuing office Florida District Office
Product type Devices
CFR sections cited 820.40, 820
Inspection city Oldsmar
Inspection ZIP 34677
Inspection start date Apr 27, 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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