Warning letter

Unipower Corporation: warning letter of Oct 18, 2007

FDA warning letter UCM076550 · Minneapolis District Office

Key facts

Reference number UCM076550
Company Unipower Corporation
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Oct 18, 2007
Posted date Oct 18, 2007
Issuing office Minneapolis District Office
Product type Devices
CFR sections cited 820, 807.20(a)(5)
Country 3
Inspection city Shakopee
Inspection ZIP 55379-1943
Inspection start date Aug 28, 2007
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • 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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