Warning letter

Visions in Endosurgery Inc.: warning letter of Nov 8, 2000

FDA warning letter UCM068993 · Florida District Office

Key facts

Reference number UCM068993
Company Visions in Endosurgery Inc.
Subject Quality System Regulation/Medical Devices/Adulterated
Issue date Nov 8, 2000
Posted date Nov 8, 2000
Issuing office Florida District Office
Product type Devices
CFR sections cited 820
Country 3
Inspection city Port Orange
Inspection ZIP 32127-4351
Inspection start date Sep 26, 2000
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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