Warning letter

Nippon Fine Chemical Co., LTD: warning letter of Sep 26, 2016

FDA warning letter 501158 · Center for Drug Evaluation and Research

Key facts

Reference number 501158
Company Nippon Fine Chemical Co., LTD
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Sep 26, 2016
Posted date Oct 3, 2016
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Takasago
Inspection start date Dec 14, 2015
Letter on fda.gov web.archive.org

At a glance

  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

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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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