Warning letter

Medelle Corporation: warning letter of Aug 2, 2006

FDA warning letter UCM076015 · Center for Devices and Radiological Health

Key facts

Reference number UCM076015
Company Medelle Corporation
Subject Sponsor Obligations
Issue date Aug 2, 2006
Posted date Aug 2, 2006
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 812.145, 812, 812.46(a), 812.46(b), 812.140(b)
Country 3
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.

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