CoLabs Intl. Corp
1 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
Thus, even if your product were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “KLĒNSKIN WASH ON SUNSCREEN” drug product is a…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
The product is misbranded because it is marketed without an approved application and does not comply with section 505G requirements for a nonprescription drug.
Supporting FDA text
Source excerpt · automated text-match checkThus, even if your product were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “KLĒNSKIN WASH ON SUNSCREEN” drug product is a misbranded drug introduced or delivered for introduction into interstate commerce in violation of sections 502(ee) and 301(a) of the FD&C Act, 21 U.S.C. 352(ee) and 331(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.
- Notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct 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 that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
- 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 correction.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.