Warning letter

Feel Tech: warning letter of Mar 15, 2013

FDA warning letter 391280 · Center for Devices and Radiological Health

Key facts

Reference number 391280
Company Feel Tech
Subject Quality System Regulation for Medical Devices/Adulterated
Issue date Mar 15, 2013
Posted date Mar 15, 2013
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Cheonan
Inspection start date Nov 19, 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:

Browse all FDA warning letters