Warning letter

Unimark Remedies Limited: warning letter of Aug 12, 2016

FDA warning letter 483816 · Center for Drug Evaluation and Research

Key facts

Reference number 483816
Company Unimark Remedies Limited
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Aug 12, 2016
Posted date Aug 23, 2016
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Ahmedabad
Inspection start date Aug 3, 2015
Letter on fda.gov web.archive.org

At a glance

  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

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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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