Grimann S.A. de C.V.
3 extracted findings · 1 model-assigned issue type
FDA source excerpt, selected passage
the active ingredients described on the carton label are dextromethorphan and guaifenesin, while the active ingredient included in the electronic listing file is propylene glycol.
FDA published a close-out letter on Jun 24, 2022. The findings below are from the original warning letter.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Active ingredients in labeling do not match the electronic listing file.
Supporting FDA text
Source excerpt · automated text-match checkthe active ingredients described on the carton label are dextromethorphan and guaifenesin, while the active ingredient included in the electronic listing file is propylene glycol.
Submitted labeling does not represent the current product; image is inconsistent.
Supporting FDA text
Source excerpt · automated text-match checkthe carton label refers to a syrup containing dextromethorphan and guaifenesin, but the Drug Facts section of the labeling includes loratadine tablets indicated for allergic rhinitis, while the listing SPL refers to propylene glycol as active ingredient.
Package type and volume in labeling do not match the electronic listing file.
Supporting FDA text
Source excerpt · automated text-match checkthe carton label image includes the size as 118 ml, while the electronic listing file includes the size as 1 U in 1 bottle.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
Source passage selected by the model
Source passage selected by the model
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 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 cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so.
- 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.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.