Warning letter

Ludwig Medical, Inc: warning letter of Aug 13, 2003

FDA warning letter UCM147653 · Chicago District Office

Key facts

Reference number UCM147653
Company Ludwig Medical, Inc
Subject Quality System Regulations/Adulterated
Issue date Aug 13, 2003
Posted date Aug 13, 2003
Issuing office Chicago District Office
Product type Devices
CFR sections cited 5, 803, 820
Country 3
Inspection city Effingham
Inspection ZIP 62401-3152
Inspection start date May 19, 2003
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:

Browse all FDA warning letters