Bioverse, Inc. dba Bioverse
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
Your claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Website claims imply compounded products are the same as FDA-approved drugs, which is false and misleading.
Supporting FDA text
Source excerpt · automated text-match checkYour claims imply that your products are the same as an FDA-approved product when they are not. As a result, these claims are false or misleading and your products are therefore misbranded under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and (bb)].
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.
- Provide a written response to the Office of Compounding Quality and Compliance (OCQC) within the Center for Drug Evaluation and Research (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.