Warning letter

Synkem [ARCHIVED]: warning letter of May 6, 2009

FDA warning letter 46778 · Center for Drug Evaluation and Research

Key facts

Reference number 46778
Company Synkem [ARCHIVED]
Subject CGMP for Deviations/Adulterated
Issue date May 6, 2009
Posted date May 6, 2009
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Chenove
Inspection start date Sep 15, 2008
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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