FDA Cites Yangzhou Hongshengding Chemical Co., Ltd. in 2026-06-15 Warning Letter — Refusal to Provide Access to and Copying of Records
Letter issued · posted to fda.gov .
Subject as published: Refusal to Provide Access to and Copying of Records
TL;DR
Here's the summary: On June 15, 2026, FDA's Center for Drug Evaluation and Research issued a warning letter to Yangzhou Hongshengding Chemical Co., Ltd. (FEI 3013166766) for refusing to provide access to records requested under section 704(a)(4) of the FD&C Act; the firm did not respond to FDA's January 20, February 4, or March 2, 2026 records requests despite confirmed delivery and an extension offer. FDA placed all drugs and drug products from the facility on Import Alert 66-79 effective June 3, 2026, and stated that future shipments may be detained or refused admission until the firm demonstrates compliance with Current Good Manufacturing Practice.
Argus analysis
# FDA Warning Letter Analysis: Yangzhou Hongshengding Chemical Co., Ltd.
The FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to Yangzhou Hongshengding Chemical Co., Ltd. on June 15, 2026, for refusing to provide records requested by the agency. The Chinese manufacturer, registered with FEI 3013166766, had resumed shipping over-the-counter drug products into the U.S. market in July 2025 after re-registering as a drug manufacturer in June 2025. The company had previously registered in October 2016 and switched to out-of-business status in July 2019. When FDA personnel contacted the firm in July 2023, company representatives stated they were no longer manufacturing drugs for the U.S. market and had no plans to resume operations.
The violations center on sections 704(a)(4) and 301(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4) and 331(e)). Section 704(a)(4) authorizes FDA to request access to and copies of records from registered drug manufacturers; section 301(e) makes it a prohibited act to refuse such access. These provisions exist to ensure the FDA can verify that manufacturers meet Current Good Manufacturing Practice standards and maintain appropriate quality assurance documentation. Between January 20 and March 2, 2026, the FDA sent three separate records requests via email and courier-delivered mail. The company's U.S. Agent requested an extension on February 9, 2026, which FDA denied, setting a February 17 deadline. The company provided no substantive response to any communication.
The company has 15 working days from receipt of the letter to respond in writing to CDER-OC-OMQ-Communications@fda.hhs.gov. On June 3, 2026, FDA placed all drugs from this manufacturer on Import Alert 66-79, effectively blocking importation. Compliance officers monitoring this case should watch for whether the company submits records, requests an inspection, or provides explanation for non-responsiveness. FDA has indicated it will withhold approval of applications listing this firm as a manufacturer until compliance is confirmed, and any imported products may face detention or refusal.
Severity context
High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
Regulatory background
FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
What peer compliance teams typically do next
Most compliance officers at peer companies use a Warning Letter against a named entity as a checklist for their own CAPA program. Common steps: pull the verbatim FDA letter; map each cited 21 CFR section against the team’s SOP library; confirm CAPA coverage; brief the QMR (Quality Management Review) on whether the cited subject matter is in scope for the next internal audit. The 15-business-day response window applies to the cited entity, not to peers — but a documented internal review against the cited subjects is what regulators expect to see if a peer is later inspected on the same topic.
Excerpt from the FDA Warning Letter (public domain, 17 USC §105)
WARNING LETTER Yangzhou Hongshengding Chemical Co., Ltd. MARCS-CMS 729710 — June 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED Reference #: 320-26-96 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Allen Lu Yangzhou Hongshengding Chemical Co., Ltd. No. 8, Sitong Road, Hangji Industrial Park Guangling Qu Yangzhou Shi Jiangsu Sheng , 225111 China 395745820@qq.com Issuing Office: Center for Drug Evaluation and Research (CDER) United States June 15, 2026 WARNING LETTER Reference Number: 320-26-96 Dear Mr. Lu: 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. Refusal to Provide Records 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…
Excerpt only. The full verbatim Warning Letter is the source of truth — always read the original before regulatory decisions.
The verbatim FDA Warning Letter is the source of truth. Always read the original before acting on any analysis or summary on this page.
Read the full letter on fda.gov ↗Frequently asked questions
- What does a "high" severity rating mean for this letter?
- High severity. Typically QSR / device CGMP, adulterated-drug, or significant labeling matters — usually drives a documented corrective and preventive action (CAPA) program.
- What is the regulatory background for a Warning Letter warning letter?
- FDA Warning Letters are administratively non-binding but signal that recurring non-compliance may escalate to injunction, seizure, import alert, or Application Integrity Policy invocation.
- What is the standard FDA response window for a warning letter?
- FDA warning letters typically require a written response within 15 working days of receipt, outlining the corrective and preventive actions the company will take.
- Has Yangzhou Hongshengding Chemical Co., Ltd. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Yangzhou Hongshengding Chemical Co., Ltd. as of 2026-06-30. Argus ingests new FDA enforcement records daily.
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methodology
The analysis above is produced by Anthropic Claude Haiku 4.5 against the verbatim FDA Warning Letter excerpt and is brand-voice lint-checked before publish. The TL;DR is the same summary that ships in the customer email digest. Severity is auto-classified by Argus from the subject string and letter body using rules documented in lib/ingestion/fda-warning-letters.ts.
Argus HQ is informational only. Summaries and analyses are AI-generated and may contain errors, misclassifications, or omissions. Verify against the FDA source URL above. Argus HQ is not a law firm, accounting firm, or regulatory agency, and provides no legal, accounting, financial, medical, or regulatory advice.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Cites Yangzhou Hongshengding Chemical Co., Ltd. in 2026-06-15 Warning Letter — Refusal to Provide Access to and Copying of Records. Digital Empire LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-yangzhou-hongshengding-chemical-co-ltd-2026-06-15-warning-letter
"FDA Cites Yangzhou Hongshengding Chemical Co., Ltd. in 2026-06-15 Warning Letter — Refusal to Provide Access to and Copying of Records." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-yangzhou-hongshengding-chemical-co-ltd-2026-06-15-warning-letter.
Argus HQ Research. "FDA Cites Yangzhou Hongshengding Chemical Co., Ltd. in 2026-06-15 Warning Letter — Refusal to Provide Access to and Copying of Records." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/fda/warning-letter/fda-wl-yangzhou-hongshengding-chemical-co-ltd-2026-06-15-warning-letter.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_yangzhou_hongshengding_chemical_co_ltd_2026_06_15_warning_letter_2026,
title = {FDA Cites Yangzhou Hongshengding Chemical Co., Ltd. in 2026-06-15 Warning Letter — Refusal to Provide Access to and Copying of Records},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-yangzhou-hongshengding-chemical-co-ltd-2026-06-15-warning-letter},
note = {Accessed: July 13, 2026}
}