Ezra Holdco LLC dba Ezra
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
The compounded semaglutide and tirzepatide products displayed on your website identify “Ezra” on the pictured label, suggesting Ezra is the compounder of those drugs when in fact it is not.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The website displayed labels identifying the company as the compounder of semaglutide and tirzepatide products when it was not.
Supporting FDA text
Source excerpt · automated text-match checkThe compounded semaglutide and tirzepatide products displayed on your website identify “Ezra” on the pictured label, suggesting Ezra is the compounder of those drugs when in fact it is not.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Identify the entities that produce the compounded drug products offered on your website.
- Provide a representative sample of labeling for such drug products.
- Address other website claims that contain false or misleading representations about your compounded drug products or demonstrate that such claims have been modified or removed.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.