Warning letter

Wuxi Medical lnstrument Factory: warning letter of Sep 7, 2017

FDA warning letter 214194 · Center for Drug Evaluation and Research

Key facts

Reference number 214194
Company Wuxi Medical lnstrument Factory
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Sep 7, 2017
Posted date Sep 7, 2017
Issuing office Center for Drug Evaluation and Research
Product type Tobacco
CFR sections cited 211.34, 211.182, 211.67(a), 211.100(a), 211.160(b)
Inspection city Wuxi
Inspection start date Mar 6, 2017
Letter on fda.gov fda.gov

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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