Warning letter

Sipra Labs Limited: warning letter of Jul 23, 2015

FDA warning letter 431553 · Center for Drug Evaluation and Research

Key facts

Reference number 431553
Company Sipra Labs Limited
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Jul 23, 2015
Posted date Aug 4, 2015
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Hyderabad
Inspection start date Feb 24, 2014
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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