Warning letter

Srikem Laboratories Pvt. Ltd.: warning letter of Nov 8, 2016

FDA warning letter 496015 · Center for Drug Evaluation and Research

Key facts

Reference number 496015
Company Srikem Laboratories Pvt. Ltd.
Subject CGMP/APIs/Adulterated
Issue date Nov 8, 2016
Posted date Nov 22, 2016
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Navi Mumbai
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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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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