Warning letter

MedGyn Products Inc.: warning letter of May 8, 2000

FDA warning letter UCM068409 · Chicago District Office

Key facts

Reference number UCM068409
Company MedGyn Products Inc.
Subject Quality System Regulation/ Obstetrical & Gynecological Devices
Issue date May 8, 2000
Posted date May 8, 2000
Issuing office Chicago District Office
Product type Devices
CFR sections cited 820
Country 3
Inspection city Addison
Inspection ZIP 60101-4508
Inspection start date Feb 3, 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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