Warning letter

Celsion Corporation: warning letter of May 17, 2004

FDA warning letter UCM146851 · Center for Devices and Radiological Health

Key facts

Reference number UCM146851
Company Celsion Corporation
Subject Sponsor Obligations
Issue date May 17, 2004
Posted date May 17, 2004
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 812.40, 812.45, 812, 812.43(d), 812.150(a)(3), 812.43(c), 812.150(b)
Country 3
Inspection city Columbia
Inspection ZIP 21046-2391
Inspection start date Dec 9, 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:

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