Warning letter

Edge Biologicals Inc: warning letter of Jun 15, 2001

FDA warning letter UCM069803 · New Orleans District Office

Key facts

Reference number UCM069803
Company Edge Biologicals Inc
Subject Quality System Regulation for Medical Devices/Adulterated
Issue date Jun 15, 2001
Posted date Jun 15, 2001
Issuing office New Orleans District Office
Product type Devices
CFR sections cited 820
Country 3
Inspection city Memphis
Inspection ZIP 38105-1634
Inspection start date May 16, 2001
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • VAI 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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