Warning letter

SmithKline Beecham (Cork) Ltd.: warning letter of Mar 18, 2014

FDA warning letter 416184 · Center for Drug Evaluation and Research

Key facts

Reference number 416184
Company SmithKline Beecham (Cork) Ltd.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Mar 18, 2014
Posted date Apr 1, 2014
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Carrigaline
Inspection start date Oct 18, 2013
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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