Warning letter

C.R. Bard, Inc.: warning letter of Sep 16, 2003

FDA warning letter UCM147712 · Atlanta District Office

Key facts

Reference number UCM147712
Company C.R. Bard, Inc.
Subject Device/Lacks Premarket Approval Application/Adulterated/Misbranded
Issue date Sep 16, 2003
Posted date Sep 16, 2003
Issuing office Atlanta District Office
Product type Devices
CFR sections cited 807.81(b), 807.3(d)(3), 807.81(a)(3)(i)
Country 3
Inspection city Covington
Inspection ZIP 30014-1497
Inspection start date Jun 2, 2003
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • VAI 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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