Guangzhou Shiruoni Cosmetics Co., Ltd

Your firm registered as a human drug manufacturer. The U.S. Food and Drug Administration (FDA) conducted testing of a consumer antiseptic rub drug product (also referred to as a consumer hand sanitizer), labeled as IMPACTA HEALTH HAND SANITIZER. This drug product was declared as being manufactured at your facility, Guangzhou Shiruoni Cosmetics Co., Ltd., FEI 3014510437, at Room 307, Bldg. 6, West Zone Union Town, 12 Dagang Road, Guangzhou, Guangdong. Following an attempt to import IMPACTA HEALTH HAND SANITIZER into the United States, it was detained and refused admission at the border.

The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product declared to be manufactured at your facility is adulterated within the meaning of section 501(d)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), 21 U.S.C. 351(d)(2), in that a substance was substituted wholly or in part therefor. In addition, this product is adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), in that the substitution demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.

In addition, IMPACTA HEALTH HAND SANITIZER is misbranded under sections 502(a) and (e)(1)(A) of the FD&C Act, 21 U.S.C. 355(a) and (e)(1)(A). Introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.

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 and 0% IPA. Therefore, this hand sanitizer drug product is adulterated under section 501(d)(2) of the FD&C Act in that the active ingredient, IPA, was substituted wholly or in part with ethanol.

On December 17, 2020, FDA held a teleconference with you. Following that teleconference, we requested additional information concerning your CGMP operations, including test methods for your finished drug product, active ingredient supplier information and certificate of analysis (COA), a statement confirming that you follow drug CGMP per 21 CFR Parts 210 and 211, and your investigation into the hand sanitizer lot where the IPA claimed on the label was substituted with ethanol. Your firm stated the employees who label the drug product cannot read English and therefore cannot verify the accuracy of the label or that it matches the formulation. In response to our requests, you stated that you do not follow 21 CFR 210 and 211 regulations to manufacture your hand sanitizers. In addition, you did not provide a COA for ethanol from your supplier, nor did you indicate if you conduct finished testing prior to releasing your drug product.

In response to this letter, provide the following:

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.

The 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.1

IMPACTA HEALTH HAND SANITIZER is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, this product is intended as a consumer topical antiseptic.

Examples of claims observed on the IMPACTA HEALTH HAND SANITIZER product label and labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:

“HAND SANTIZER. . . Drug Facts. . . Antiseptic . . . Uses: Hand sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available. . . Directions – Place enough product on hands to cover all surfaces. Rub hands together until dry.”

This hand sanitizer is misbranded under section 502(a) of the FD&C Act, 21 U.S.C 352(a), because its labeling is false or misleading. IMPACTA 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. Therefore, a labeling representation suggesting that your product is FDA-approved is false or misleading.

Additionally, according 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. While ethanol as a sole active ingredient is permitted for use as a consumer or health care personnel antiseptic hand rub, it is not declared on the product label. Thus, the misleading representation of the concentration of the active ingredient isopropyl alcohol and the failure of the product label to disclose the presence of the ethanol in the product cause IMPACTA HEALTH HAND SANITIZER to be misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a).

The 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).

The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements if your firm intends to resume manufacturing drugs for the U.S. market. We also recommend that the qualified consultant perform a comprehensive audit of your entire operation for CGMP compliance and that the consultant evaluates the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

The violations cited in this letter are not intended to be an all-inclusive list of violations associated with your drug products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Note that FDA placed all drugs and drug products manufactured by your firm on Import Alert 66-78 on March 10, 2021, as the methods used in and controls used for the manufacture, processing, packing, or holding of these products do not appear to conform to current good manufacturing practices within the meaning of section 501(a)(2)(B) of the FD&C Act. Drugs and drug products that appear to be adulterated or misbranded may be detained or refused admission without physical examination.

All drugs and drug products manufactured by your firm may remain listed on this import alert until there is evidence establishing that the conditions that gave rise to the appearance of a violation have been resolved, and the Agency has confidence that future entries will be in compliance with the FD&C Act. This may include an inspection prior to the Agency considering the appearance of adulteration to be addressed.

If you decide you want to manufacture drugs for the United States in the future, request a Regulatory Meeting to discuss corrective actions.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot do so within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov.

Please identify your response with FEI 3014510437 and ATTN: Runa Musib.