Warning letter

EPS Biotechnology Corp.: warning letter of Sep 11, 2012

FDA warning letter 333178 · Center for Devices and Radiological Health

Key facts

Reference number 333178
Company EPS Biotechnology Corp.
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Sep 11, 2012
Posted date Sep 11, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Hsinchu
Inspection start date Jun 18, 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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