Short answer: Guangdong Bisutang Biotechnology Co., Ltd., a Chinese facility registered with FDA as a manufacturer of over-the-counter drugs including sunscreen, never answered FDA's records requests under section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA placed all its drugs on Import Alert 66-79 on July 31, 2026 and issued a warning letter on October 27, 2026 that also cited a color additive FDA cancelled in 1966.
This article summarizes a public FDA warning letter and import-alert entry. The company named in those records is not identified as an FDABridge client, and neither record reports illnesses or a recall.
What happened to the Chinese sunscreen manufacturer?
Import records showed multiple US shipments declaring the facility in Zhaoqing, Guangdong, as the manufacturer. On May 1, 2026, FDA sent an electronic section 704(a)(4) request for records to the contact email in the firm's registration file and to its U.S. agent. FDA followed up with a second electronic request on May 19, a phone call to the listed U.S. agent on May 27 and a written request sent by UPS on May 28, 2026.
A facility representative signed for the UPS package, yet the firm answered none of these communications and provided no records, although FDA says its requests clearly described the records sought. With nothing to review, FDA wrote that it had no indication of the level of quality assurance for drugs listed as made at the facility.
Why did FDA act without inspecting the factory?
Section 704(a)(4) lets FDA request, and requires drug establishments to provide, records FDA could inspect, in advance of or in lieu of an inspection. FDA's June 2025 final guidance on remote regulatory assessments says these mandatory requests are made on Form FDA 4003 and may go to the point of contact listed in the registration. FDA may ask for a response within 15 calendar days, or 30 when translation is requested, and an establishment that refuses may be in violation of the FD&C Act.
The warning letter calls refusing access to or copying of required records a prohibited act under section 301(e). Import Alert 66-79 covers drugs from foreign establishments refusing FDA inspection and rests on section 501(j), which makes a drug adulterated when the owner, operator or agent of an establishment delays, denies or limits an inspection or refuses entry or inspection. The alert expressly includes 704(a)(4) records requests, covers all of this firm's drugs and says listed firms' drugs should generally stay subject to detention until FDA completes an inspection. The letter invited the firm to request one.
What did the listing and import records reveal?
FDA found a second problem in the firm's own drug listing: a sunscreen listed as XUEYI SKIN CARE contains CI 11680, which the letter identifies as Ext. D&C Yellow No. 5. Under 21 CFR 81.30(d), certificates for that color were cancelled and have no effect after October 4, 1966, and its use in foods, drugs or cosmetics after that date results in adulteration. FDA found the sunscreen adulterated under section 501(a)(4)(A) and noted that this color is not the listed color additive FD&C Yellow No. 5.
FDA also noted apparent discrepancies in electronic import entries, specifically a failure to declare the drug listing correctly. Under 21 CFR 1.74(a)(1), the entry filer must submit the foreign establishment's drug registration number and the drug listing number, which is the product's National Drug Code. FDA told the firm to ensure that shippers, importers and entry filers declare it as manufacturer with its registration and listing numbers. It also reminded the firm that its cosmetics must comply with the FD&C Act and that MoCRA sets requirements for cosmetic manufacturing facilities.
What should the manufacturer have checked?
Every channel FDA tried was one the firm controlled or had named itself. Under 21 CFR 207.69, a drug registrant's official contact must keep registration and listing information accurate and review, route and respond to all FDA communications. A foreign registrant's U.S. agent must reside or maintain a place of business in the United States, cannot be a mailbox or answering service, and must also route and respond to FDA communications. If FDA cannot reach the registrant directly or expeditiously, information given to the agent counts as given to the registrant.
- Monitor the registration contact email and keep official contact and U.S. agent details current.
- Agree in writing how the U.S. agent forwards FDA requests and who at the facility owns the reply.
- Know where batch records, specifications, test results and procedures are kept, and who will translate them if FDA asks.
- Check each colorant's US status for drugs instead of relying on a CI number accepted in another market.
- Make sure importers and brokers declare the actual manufacturer, its registration number and the correct NDC.
- Keep MoCRA filings for the facility's cosmetics separate from its drug registration and listings.
Related guidance
Background reading: sunscreens as OTC drugs in the US, U.S. agent roles by product type, drug listing duties under 21 CFR 207, color additive rules for cosmetics, inspections and remote assessments of foreign drug facilities and, for cosmetics, FDA records access and mandatory recalls under MoCRA.
How FDABridge helps
FDABridge's drug establishment registration service covers 21 CFR Part 207 registration, first-year U.S. agent coverage and annual re-registration support. As U.S. agent, FDABridge is a contact point for FDA communications relevant to that role and routes them to the facility; agent coverage alone does not include inspection responses or import-alert work (see the U.S. Agent service). SPL drug listings and NDC labeler codes are separate services, as are MoCRA filings for cosmetic facility registration and cosmetic product listing. Registration and listing are not FDA approval.
Sources: FDA warning letter to Guangdong Bisutang Biotechnology Co., Ltd., MARCS-CMS 733939, October 27, 2026 (https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/guangdong-bisutang-biotechnology-co-ltd-733939-10272026); FDA Import Alert 66-79 (https://www.accessdata.fda.gov/cms_ia/importalert_1174.html); FDA, Conducting Remote Regulatory Assessments: Questions and Answers, final guidance, June 2025 (https://www.fda.gov/media/160173/download); 21 CFR 207.69 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-207/subpart-F/section-207.69); 21 CFR 81.30 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-81/section-81.30); 21 CFR 1.74 (https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1/subpart-D/section-1.74).