Warning letter

Apotex Pharmachem India Pvt Ltd.: warning letter of Jun 16, 2014

FDA warning letter 423752 · Center for Drug Evaluation and Research

Key facts

Reference number 423752
Company Apotex Pharmachem India Pvt Ltd.
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Jun 16, 2014
Posted date Jun 16, 2014
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Bangalore
Inspection start date Jan 27, 2014
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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