Warning letter

SagaTech Electronics, Inc.: warning letter of Apr 7, 2003

FDA warning letter UCM147415 · Center for Devices and Radiological Health

Key facts

Reference number UCM147415
Company SagaTech Electronics, Inc.
Subject Quality System Regulation for Medical Devices/Adulterated
Issue date Apr 7, 2003
Posted date Apr 7, 2003
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Country 3
Inspection city Calgary
Inspection start date Dec 2, 2002
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