Warning letter

Torrent Pharmaceuticals Limited: warning letter of Oct 8, 2019

FDA warning letter 585255 · Center for Drug Evaluation and Research

Key facts

Reference number 585255
Company Torrent Pharmaceuticals Limited
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Oct 8, 2019
Posted date Oct 15, 2019
Issuing office Center for Drug Evaluation and Research
Product type Drugs
CFR sections cited 211.34, 211.192, 211.100(b)
Inspection city Indrad
Inspection start date Apr 8, 2019
Letter on fda.gov fda.gov

At a glance

  • 1–9 CFR sections cited
  • 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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