Warning letter

Covidien LP: warning letter of Jun 14, 2012

FDA warning letter 282277 · New England District Office

Key facts

Reference number 282277
Company Covidien LP
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Jun 14, 2012
Posted date Jun 14, 2012
Issuing office New England District Office
Product type Devices
CFR sections cited 820
Inspection city North Haven
Inspection ZIP 06473
Inspection start date Jan 13, 2012
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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