Warning letter

Huaiyin Medical Instruments Co., Ltd. [ARCHIVED]: warning letter of Nov 20, 2009

FDA warning letter 76344 · Center for Devices and Radiological Health

Key facts

Reference number 76344
Company Huaiyin Medical Instruments Co., Ltd. [ARCHIVED]
Subject CGMP/QSR/Medical Devices/Adulterated
Issue date Nov 20, 2009
Posted date Nov 20, 2009
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 803, 820
Inspection city Huaian
Inspection start date Mar 30, 2009
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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