Warning letter

Sure On Industries Ltd.: warning letter of Aug 6, 2012

FDA warning letter 319538 · Center for Devices and Radiological Health

Key facts

Reference number 319538
Company Sure On Industries Ltd.
Subject Medical Device Reporting/Misbranded
Issue date Aug 6, 2012
Posted date Aug 6, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803.17, 803, 820
Inspection city Dongguan
Inspection start date May 28, 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.

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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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