Warning letter

Flextronics Electronics Technology (Suzhou) Co., Ltd.: warning letter of Feb 19, 2015

FDA warning letter 445443 · Center for Devices and Radiological Health

Key facts

Reference number 445443
Company Flextronics Electronics Technology (Suzhou) Co., Ltd.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Feb 19, 2015
Posted date Sep 1, 2015
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Suzhou
Inspection start date Oct 13, 2014
Letter on fda.gov web.archive.org

At a glance

  • 1–9 CFR sections cited
  • NAI 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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