Warning letter

Shanghai Apolo Medical Technology Co., Ltd: warning letter of Feb 23, 2012

FDA warning letter 268897 · Center for Devices and Radiological Health

Key facts

Reference number 268897
Company Shanghai Apolo Medical Technology Co., Ltd
Subject Adulterated Device
Issue date Feb 23, 2012
Posted date Feb 23, 2012
Issuing office Center for Devices and Radiological Health
Product type Devices
CFR sections cited 820, 807.81(b), 820.40
Inspection city Shanghai
Inspection start date Sep 5, 2011
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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