Warning letter

Acuderm Inc: warning letter of Jan 8, 2004

FDA warning letter UCM146130 · Florida District Office

Key facts

Reference number UCM146130
Company Acuderm Inc
Subject QSR for Medical Devices/Medical Device Reporting/Adulterated
Issue date Jan 8, 2004
Posted date Jan 8, 2004
Issuing office Florida District Office
Product type Devices
CFR sections cited 803, 820, 820.40
Country 3
Inspection city Ft Lauderdale
Inspection ZIP 33309-6335
Inspection start date Oct 8, 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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