By September 30, 2027, will the U.S. FDA have posted a close-out letter for Warning Letter 726976, issued to FairyGene, Inc.?

On July 31, 2026, the U.S. Food and Drug Administration (FDA) issued Warning Letter 726976 to FairyGene, Inc. The letter details significant violations of Current Good Manufacturing Practice regulations, including an unsuitable manufacturing environment and a lack of controls to prevent contamination. An FDA close-out letter would indicate the agency has verified that the company has taken sufficient corrective action.

How this question entered the record and how it will be resolved.

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Resolution criteria

This question will resolve to 'Yes' if, by September 30, 2027, the U.S. FDA's public database of warning letters indicates that a close-out letter has been issued for Warning Letter 726976 concerning FairyGene, Inc. Otherwise, this question will resolve to 'No'. The primary resolution source will be the FDA's warning letters database (www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters).

Expected resolution

Sep 30, 2027

• FDA Issues Warning Letter to FairyGene, Inc.