Guangzhou Shiruoni Cosmetics Co., Ltd
5 extracted findings · 3 model-assigned issue types
FDA source excerpt, selected passage
IMPACTA HEALTH HAND SANITIZER declared to be manufactured at your facility, is labeled to contain 75% volume/volume (v/v) of the active ingredient isopropyl alcohol (IPA). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average 67% v/v ethanol…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Hand sanitizer labeled with 75% v/v isopropyl alcohol was found to contain 67% v/v ethanol and no isopropyl alcohol, constituting active ingredient substitution.
Supporting FDA text
Source excerpt · automated text-match checkIMPACTA HEALTH HAND SANITIZER declared to be manufactured at your facility, is labeled to contain 75% volume/volume (v/v) of the active ingredient isopropyl alcohol (IPA). However, FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average 67% v/v ethanol and 0% IPA.
The substitution demonstrates that quality assurance does not comply with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.
Supporting FDA text
Source excerpt · automated text-match checkThe substitution in a drug product declared as manufactured in your facility demonstrates that the quality assurance within your facility is not functioning in accordance with CGMP requirements under section 501(a)(2)(B) of the FD&C Act.
The product label is false or misleading because it includes an FDA approval claim, as the product is not the subject of an FDA-approved application.
Supporting FDA text
Source excerpt · automated text-match checkIMPACTA HEALTH HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because your webpage misleadingly implies that IMPACTA HEALTH HAND SANITIZER is FDA approved. For example, the description of the product states “FDA-Approved Hand Sanitizer.” However, IMPACTA HEALTH HAND SANITIZER product is not the subject of an FDA-approved application.
The label misrepresents the active ingredient concentration and fails to disclose undeclared ethanol, making the labeling false or misleading.
Supporting FDA text
Source excerpt · automated text-match checkaccording to the product label, IMPACTA HEALTH HAND SANITIZER purportedly contains the active ingredient Isopropyl Alcohol 75% v/v. However, FDA laboratory analyses of batches of this product demonstrated that IMPACTA HEALTH HAND SANITIZER does not contain a detectable concentration of isopropyl alcohol. Furthermore, analyses revealed that the product contained concentrations of the undeclared ingredient, ethanol at 66.9% v/v.
The product fails to list ethanol on the label, resulting in misbranding under section 502(e)(1)(A) of the FD&C Act.
Supporting FDA text
Source excerpt · automated text-match checkThe failure of this drug product to list ethanol as an ingredient on its label also causes it to be misbranded under section 502(e)(1)(A) of the FD&C Act, 21 U.S.C. 352(e)(1)(A).
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- A detailed investigation into how the drug product described above, which was declared as manufactured at your facility and which was labeled as containing IPA, was substituted in part or in whole with ethanol.
- A list of all batches of any hand sanitizer drug products shipped to the United States by your firm, and a full reconciliation of all material you distributed.
- Copies of the complete batch records for all batches distributed to the United States.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.