Derma Solution
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
your website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The website offers unapproved and misbranded injectable botulinum toxin products for sale to U.S. consumers.
Supporting FDA text
Source excerpt · automated text-match checkyour website introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 353(b), and 355(a)]
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 an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation.
- If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections.
- If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.