Warning letter

Sanmina-SCI AB: warning letter of Apr 11, 2014

FDA warning letter 423189 · Center for Devices and Radiological Health

Key facts

Reference number 423189
Company Sanmina-SCI AB
Subject Medical Devices/Adulterated/Quality System Regulation (QSR)
Issue date Apr 11, 2014
Posted date Apr 11, 2014
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Ornskoldsvik
Inspection start date Dec 9, 2013
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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