Yangzhou Hongshengding Chemical Co., Ltd.

This Warning Letter advises you of significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations for Yangzhou Hongshengding Chemical Co., Ltd. (hereafter YHC), FEI 3013166766, located at No. 8, Sitong Road, Hangji Industrial Park, Guangling District, Yangzhou.

Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products.

A review of import records showed multiple shipments of OTC drug products into the U.S. market, which declared YHC as the drug manufacturer. The FDA sent several requests 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 email address provided in your registration file. These requests went unanswered by your firm.

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 having been manufactured at your facility.

According to FDA records, your firm initially registered as a drug manufacturer in October 2016 and then had your registration switched to out-of-business in July 2019. FDA staff contacted your firm in July 2023 and were informed that your firm was still in business. Personnel from your firm stated at that time that you had not manufactured or shipped any drug products intended for the U.S. market in several years and did not have any future plans to do so.

In June 2025 your firm re-registered with FDA as a drug manufacturer, and you resumed drug shipments to the U.S. market the following month. On January 20, 2026, the FDA sent an initial electronic request for records and other information, pursuant to section 704(a)(4) to the contact email address provided in your registration file and your U.S. Agent. This request went unanswered.

A second request to your firm and to your U.S. Agent was sent via email on February 4, 2026. Your U.S. Agent responded on February 9, 2026, requesting an extension until March 5, 2026. FDA responded that the deadline for providing records would be extended only until February 17, 2026. FDA received no response to this communication.

FDA sent a follow-up written request for such records and other information on March 2, 2026. The shipper confirmed delivery of the written request to your firm1, but you failed to respond to these attempted communications or to provide the requested records or information. Pursuant to section 704(a)(4), FDA’s request and follow-up communication included a sufficient and clear description of the records being sought.

The violations cited in this letter are not intended to be an all-inclusive list of violations 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 June 3, 2026.

Until FDA can confirm your compliance with Current Good Manufacturing Practice 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 Yangzhou Hongshengding Chemical Co., Ltd., located at No. 8, Sitong Road, Hangji Industrial Park, Guangling District, Yangzhou, coming into the U.S. market 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, please respond to this office in writing within 15 working days. In response to this letter, you may provide information for our consideration as we continue to assess your activities and practices, and/or you may submit a request to schedule an FDA inspection.

Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3013166766 and ATTN: Ernest Bizjak in the subject line.

Please note that FDA posts Warning Letters on www.FDA.gov.