Warning letter

SCM True Air Technologies LLC: warning letter of Sep 24, 2007

FDA warning letter UCM076509 · Cincinnati District Office

Key facts

Reference number UCM076509
Company SCM True Air Technologies LLC
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 24, 2007
Posted date Sep 24, 2007
Issuing office Cincinnati District Office
Product type Devices
CFR sections cited 880.5550, 820
Country 3
Inspection city Louisville
Inspection ZIP 40228-1044
Inspection start date Aug 16, 2007
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