Warning letter

Guilin Zizhu Latex Co., Ltd: warning letter of Aug 14, 2015

FDA warning letter 455114 · Center for Devices and Radiological Health

Key facts

Reference number 455114
Company Guilin Zizhu Latex Co., Ltd
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Aug 14, 2015
Posted date Sep 14, 2015
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820
Inspection city Guilin
Inspection start date Mar 2, 2015
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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