Warning letter

Syntee Scientific Corp.: warning letter of Sep 30, 2005

FDA warning letter UCM075589 · Center for Devices and Radiological Health

Key facts

Reference number UCM075589
Company Syntee Scientific Corp.
Subject CGMP Medical Device Reporting/Adulterated/Misbranded
Issue date Sep 30, 2005
Posted date Sep 30, 2005
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820, 803, 803.17
Country 3
Inspection city Chang Hua
Inspection start date May 2, 2005
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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