Warning letter

Focus Imaging Group Inc.: warning letter of May 11, 2000

FDA warning letter UCM068425 · Florida District Office

Key facts

Reference number UCM068425
Company Focus Imaging Group Inc.
Subject Diagnostic Ultrasound Equipment/Lacks Premarket Approval/Misbranded
Issue date May 11, 2000
Posted date May 11, 2000
Issuing office Florida District Office
Product type Devices
Country 3
Inspection city Pompano Beach
Inspection ZIP 33073-3081
Inspection start date Feb 22, 2000
Letter on fda.gov web.archive.org

At a glance

  • 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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