Warning letter

Vital Laboratories Pvt Ltd Plant II: warning letter of Oct 10, 2017

FDA warning letter 527253 · Center for Drug Evaluation and Research

Key facts

Reference number 527253
Company Vital Laboratories Pvt Ltd Plant II
Subject CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Issue date Oct 10, 2017
Posted date Oct 24, 2017
Issuing office Center for Drug Evaluation and Research
Product type Drugs
Inspection city Vapi
Inspection start date Apr 3, 2017
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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