Warning letter

Macan Engineering and Manufacturing Company Inc.: warning letter of Sep 15, 2005

FDA warning letter UCM075563 · Chicago District Office

Key facts

Reference number UCM075563
Company Macan Engineering and Manufacturing Company Inc.
Subject Quality System Regulation for Medical Devices/Adulterated/Misbranded
Issue date Sep 15, 2005
Posted date Sep 15, 2005
Issuing office Chicago District Office
Product type Devices
CFR sections cited 820
Country 3
Inspection city Chicago
Inspection ZIP 60622-1942
Inspection start date Jun 21, 2005
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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