Warning letter

Hubei Danao Pharmaceutical Co., Ltd.: warning letter of Nov 6, 2017

FDA warning letter 539667 · Center for Drug Evaluation and Research

Key facts

Reference number 539667
Company Hubei Danao Pharmaceutical Co., Ltd.
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Nov 6, 2017
Posted date Nov 21, 2017
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Shiyan
Inspection start date Jul 31, 2017
Letter on fda.gov fda.gov

At a glance

  • 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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