Warning letter

Lupin Limited: warning letter of Sep 27, 2022

FDA warning letter 633703 · Center for Drug Evaluation and Research | CDER

Key facts

Reference number 633703
Company Lupin Limited
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Sep 27, 2022
Posted date Nov 1, 2022
Issuing office Center for Drug Evaluation and Research | CDER
Product type Drugs
Inspection city Tarapur, Thane
Inspection start date Mar 22, 2022
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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