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U.S. Department of Health and Human Services

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Warning and Untitled Letters - Summary of Public Comments

View PDF of Warning and Untitled Letters Section (26 KB)


Background

Transparency Report Arrow Summary of Public Comments

Considerations

View All Warning and Untitled Letters Draft Proposals


Summary of Public Comments

Individuals and consumer groups suggested that FDA disclose all warning letters and untitled letters issued by the Agency.  They argued that the public should be informed about firms FDA has determined are in violation of the law and the rationale underlying FDA’s determination, so that members of the public can make more informed decisions about FDA-regulated products.