Warning letter

CTX Lifesciences Private Ltd.: warning letter of Jan 18, 2017

FDA warning letter 496393 · Center for Drug Evaluation and Research

Key facts

Reference number 496393
Company CTX Lifesciences Private Ltd.
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Jan 18, 2017
Posted date Jan 31, 2017
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Surat
Inspection start date Feb 15, 2016
Letter on fda.gov fda.gov

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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