Warning letter

Fareva Morton Grove: warning letter of Mar 3, 2026

FDA warning letter 719408 · Center for Drug Evaluation and Research (CDER)

Key facts

Reference number 719408
Company Fareva Morton Grove
Subject CGMP/Finished Pharmaceuticals/Adulterated
Issue date Mar 3, 2026
Posted date Mar 10, 2026
Issuing office Center for Drug Evaluation and Research (CDER)
Product type Drugs
CFR sections cited 211.63, 211.165(b), 211.194(a)
Inspection city Morton Grove
Inspection ZIP 60053
Inspection start date Aug 4, 2025
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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