Warning letter

Signal Medical Corporation [ARCHIVED]: warning letter of Jun 30, 2011

FDA warning letter 199932 · Detroit District Office

Key facts

Reference number 199932
Company Signal Medical Corporation [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 30, 2011
Posted date Jun 30, 2011
Issuing office Detroit District Office
Product type Devices
CFR sections cited 820, 820.40
Inspection city Marysville
Inspection ZIP 48040
Inspection start date Mar 17, 2011
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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