Guangdong Bisutang Biotechnology Co., Ltd.

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October 27, 2026

WARNING LETTER
Reference number: 320-27-11

To Mr. Jianfang Chen:

This warning letter advises you of significant violations identified during a U.S. Food and Drug Administration (FDA) review of records submitted from your facility and provides you an opportunity to address them. Promptly address any violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations in connection with your products. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address any violations may result in regulatory action without further notice.

FDA Review

Violations were identified and documented during review of your drug manufacturing facility, Guangdong Bisutang Biotechnology Co., Ltd., FDA Establishment Identifier (FEI) 3031796296. This review was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

Your facility is registered with the FDA as a manufacturer of over-the-counter (OTC) drug products, including sunscreen.

A review of import records showed multiple shipments of products into the United States, which declared Guangdong Bisutang Biotechnology Co., Ltd., as the manufacturer. On May 1, 2026, FDA sent an initial electronic request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 374(a)(4), to the contact e-mail address provided in your registration file and to your U.S. Agent. This request went unanswered as did numerous follow-up requests, including a second electronic request sent on May 19, 2026, and a separate phone call to the listed U.S. Agent of record on May 27, 2026. Additionally, FDA sent a follow-up written request for such records and other information by United Parcel Service (UPS) on May 28, 2026. Delivery of the UPS package was confirmed by signature of your facility representative, but you failed to respond to any of these attempted communications or otherwise provide the requested records or other information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records sought.

It is a prohibited act under section 301(e) of the FD&C Act (21 U.S.C. 331(e)) to refuse to permit access to or copying of any record as required by section 704(a). Because your firm failed to respond to the section 704(a)(4) records requests and associated communication attempts, we have no indication of the level of quality assurance for drugs listed as manufactured at your facility.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-79 on July 31, 2026.

Use of Cancelled Color Additive Ext. D&C Yellow No. 5

Based on your drug product listing we determined that your “XUEYI SKIN CARE” sunscreen is adulterated under section 501(a)(4)(A) of the FD&C Act as this FDA-listed drug product bears or contains a color additive that is unsafe within the meaning of section 721 of the FD&C Act, 21 U.S.C. 379e. Specifically, your “XUEYI SKIN CARE” sunscreen drug product contains the cancelled color additive CI 11680 (also known as Ext. D&C Yellow No. 5¹). In 1966, FDA cancelled the certification and delisted Ext D&C Yellow No. 5 due to lack of safety data from any manufacturer. Under 21 CFR 81.30(d), using Ext D&C Yellow No. 5 after October 4, 1966, results in the drug being adulterated. Your use of a cancelled color additive in your drug product formulation renders it adulterated under 501(a)(4)(A). Accordingly, the introduction or delivery for introduction of “XUEYI SKIN CARE” sunscreen into interstate commerce is a prohibited act under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

For more information regarding color nomenclature see the webpage for Regulatory Status of Color Additives at: https://www.hfpappexternal.fda.gov/scripts/fdcc/index.cfm?set=ColorAdditives.

Drug Import Information

You manufacture both drug and cosmetic products. Based on information from FDA import records, there appear to be discrepancies in the electronic import entry submissions for your products, specifically regarding the failure to correctly declare your drug product listing. Prior to distributing products intended for the United States, you should ensure that the firms shipping or importing your drug products, and the entry filers transmitting the electronic data to U.S. Customs and Border Protection and FDA, are declaring your firm as the manufacturer, as well as using your registration number and product listing number(s). See 21 CFR 1.74(a)(1).

Cosmetics Manufactured for Distribution in the United States

In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act (21 U.S.C. 321(i)). Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act (21 U.S.C. 331(a)), it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.

We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.

Conclusion

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-79 on July 31, 2026.

Until FDA is able to confirm compliance with CGMP and other applicable requirements, we may withhold approval of any new applications or supplements listing your firm as a drug manufacturer. In addition, shipments of articles manufactured at Guangdong Bisutang Biotechnology Co., Ltd., at Floor 1-5, One of No. 15 (Factory Building 1-1), Industrial Cluster Development Zone, Xiamao Town, Zhaoqing into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). After you receive this letter, respond to this office in writing within 15 working days. In response to this letter, you may submit a request to schedule an FDA inspection.

Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your written response with FEI 3031796296 and ATTN: Lynnsey Renn in the letter or in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

FDA posts warning letters to www.FDA.gov.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

cc:
Faye Liang & Clare Ho
US Agent
(b)(4)

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1 Not to be confused with the similar sounding but listed color additive Food, Drug, and Cosmetic (FD&C) Yellow 5