Guangzhou Zhongkebaishi Health Industry Co., Ltd.
12 extracted findings · 6 model-assigned issue types
FDA source excerpt, selected passage
FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 51% volume/volume (v/v) ethanol. This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the…
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Hand sanitizer labeled as containing 75% ethanol was found to contain only 51% ethanol, making it subpotent.
Supporting FDA text
Source excerpt · automated text-match checkFDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 51% volume/volume (v/v) ethanol. This hand sanitizer drug product is adulterated under section 501(c) of the FD&C Act in that the active ingredient of ethanol is present at levels in the product lower than that which is declared on its labeling.
Subpotency demonstrates quality assurance not functioning per CGMP.
Supporting FDA text
Source excerpt · automated text-match checkthe subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
Failed to provide documentation of finished product test methods, analytical procedures, impurity testing, stability reports, or batch records.
Supporting FDA text
Source excerpt · automated text-match checkyou did not provide any documentation of your finished product test methods, analytical procedures, impurity testing, stability reports or batch records.
Without adequate testing of incoming raw materials and finished product, cannot assure products conform to standards.
Supporting FDA text
Source excerpt · automated text-match checkWithout adequate testing of incoming raw materials and finished product, as required under 21 CFR 211.84 and 21 CFR 211.165 respectively, you cannot assure that your drug products conform to appropriate standards of identity, strength, quality and purity.
Failed to provide a detailed investigation into how the hand sanitizer was manufactured with subpotent ethanol.
Supporting FDA text
Source excerpt · automated text-match checkYou explained this was a one-time accident but did not provide a detailed investigation.
Product is an unapproved new drug marketed without FDA approval.
Supporting FDA text
Source excerpt · automated text-match checkthis product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act
Labeling is false or misleading because it claims 75% ethanol while product contains far less.
Supporting FDA text
Source excerpt · automated text-match checkthe misleading representation of the concentration of the active ingredient ethanol on the Hand Sanitizer Gel labeling cause this product to be misbranded under section 502(a) of the FD&C Act
Misbranded because the FDA logo on the label falsely implies approval.
Supporting FDA text
Source excerpt · automated text-match checkthe “FDA” logo is displayed on the product principal display panel which creates the impression that the drug is approved or legally marketable (see 21 CFR 207.77(b)).
Misbranded because the Drug Facts label lacks required headings and is not organized per 21 CFR 201.66.
Supporting FDA text
Source excerpt · automated text-match checkyour product label fails to include headings for the Active ingredient(s) and Purpose(s), nor is the “Drug Facts” panel labeled, organized, or presented in accordance with 21 CFR 201.66(c). Therefore, this product is misbranded under section 502(c) of the FD&C Act
Misbranded because Drug Facts panel contains extraneous information outside the required content.
Supporting FDA text
Source excerpt · automated text-match checkyour Drug Facts panel contains a “Properties & Functions” section which includes extraneous statements such as "Leaves skin feeling soft, dry, and free."
Misbranded because the label fails to disclose a domestic address or telephone number for adverse event reporting.
Supporting FDA text
Source excerpt · automated text-match checkthe product label fails to disclose a complete domestic address or domestic telephone number through which the responsible person may receive a report of a serious adverse event with such drug.
Misbranded because it does not comply with requirements for marketing without an approved application under 505G.
Supporting FDA text
Source excerpt · automated text-match checkHand Sanitizer Gel is a nonprescription drug subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505
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 hand sanitizer product described above, labeled as containing 75% ethanol, in fact contained an average of 51% ethanol.
- A list of all raw materials used to manufacture your hand sanitizer drug products, including the suppliers’ names, addresses, and contact information.
- 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.