All American Wellness
2 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
“Mounjaro’s compounded version- Tirzepatide Prescription”
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Website claims falsely imply compounded products are the same as FDA-approved Mounjaro and Ozempic.
Supporting FDA text
Source excerpt · automated text-match check“Mounjaro’s compounded version- Tirzepatide Prescription”
Website claims falsely imply compounded products are the same as FDA-approved Mounjaro and Ozempic.
Supporting FDA text
Source excerpt · automated text-match check“Ozempic’s compounded version- Semaglutide”
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
“Mounjaro’s compounded version- Tirzepatide Prescription”
Source passage selected by the model
02
“Ozempic’s compounded version- Semaglutide”
Source passage selected by the model
What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Provide a written response to the Office of Compounding Quality and Compliance (OCQC) within CDER's Office of Compliance describing the specific steps taken to address any violations.
- Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
- If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration.
- If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.