Warning letter

Ningbo Huahui Medical Instruments Co., LTD: warning letter of Jul 16, 2012

FDA warning letter 314879 · Center for Devices and Radiological Health

Key facts

Reference number 314879
Company Ningbo Huahui Medical Instruments Co., LTD
Subject CGMP/QSR/Medical Devices/Adulterated/Misbranded
Issue date Jul 16, 2012
Posted date Jul 16, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820, 803
Inspection city NINGBO
Inspection start date Apr 16, 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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