Warning letter

Smruthi Organics Limited: warning letter of Mar 6, 2014

FDA warning letter 416931 · Center for Drug Evaluation and Research

Key facts

Reference number 416931
Company Smruthi Organics Limited
Subject CGMP/Finished Pharmaceuticals/Adulterated/HPLC
Issue date Mar 6, 2014
Posted date Mar 23, 2014
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Solapur District, Maharashtra
Inspection start date Oct 15, 2013
Letter on fda.gov web.archive.org

At a glance

  • OAI Linked inspection classification
  • Yes Form FDA 483 issued

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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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