FDA Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (2026-09-23) — CGMP/Finished Pharmaceuticals/Adulterated
Letter issued · posted to fda.gov .
Subject as published: CGMP/Finished Pharmaceuticals/Adulterated
TL;DR
The short version: The FDA (Center for Drug Evaluation and Research) issued a warning letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (FEI 3014159182), Guangdong, China on September 23, 2026, following an inspection conducted November 3–7, 2025, citing multiple CGMP violations for finished pharmaceuticals. The violations include: labeling OTC products as "sterile" without performing sterility testing or establishing sterility assurance procedures; failing to test incoming components for identity and conformity with specifications; and relying on supplier certificates of analysis without validating supplier reliability, particularly for high-risk components requiring USP testing for hazardous impurities. The letter states the firm's drug products are adulterated under the FD&C Act and requires submission of an action plan addressing product quality risks, patient safety, and potential recalls or market withdrawals for sterile-labeled products in U.S. distribution.
Argus analysis
# FDA Warning Letter Analysis: Jiangmen Shuizirun Sanitary Articles Co., Ltd.
The FDA's Center for Drug Evaluation and Research (CDER) issued a warning letter on September 23, 2026, to Jiangmen Shuizirun Sanitary Articles Co., Ltd., a Chinese manufacturer of over-the-counter drug products. The inspection, conducted November 3–7, 2025, at the facility in Guangdong Province, identified significant Current Good Manufacturing Practice (CGMP) violations affecting finished pharmaceuticals. The FDA determined that products do not conform to CGMP requirements, rendering them adulterated under the Federal Food, Drug, and Cosmetic Act.
The violations center on two principal areas. First, the company failed to establish procedures preventing microcontamination in products labeled as sterile, violating 21 CFR 211.113(b). Despite labeling certain OTC products as sterile, the firm did not perform sterility testing at release and relied on microbial counts that fell below specifications for sterile drugs. Second, under 21 CFR 211.84(d)(1), 211.84(d)(2), and 211.110(c), the company failed to test incoming component lots for identity and conformity with written specifications and did not validate supplier testing at appropriate intervals. The violations involve high-risk components requiring USP limit testing to detect hazardous impurities, including materials with documented lethal poisoning incidents associated with contamination.
The FDA requested a response without specifying a firm deadline, though standard practice allows 15 working days. The agency demanded specific corrective and preventive actions: identity testing protocols for all incoming lots, risk assessments for potentially contaminated products, supplier qualification reviews, and potential product recalls or customer notifications for affected batches. Compliance officers in pharmaceutical manufacturing should monitor whether the company issues recalls, implements supplier audits, and establishes enhanced testing procedures. Subsequent FDA inspection or regulatory action remains possible if responses prove inadequate.
Severity context
Critical severity. Typically reserved for data integrity, sterile-product CGMP, or repeat violations — matters that historically precede injunctions, consent decrees, or import alerts.
Regulatory background
CGMP citations typically reference 21 CFR Part 211 (drugs) or 21 CFR Part 600 (biologics). Common subjects include identity testing of incoming components (211.84), validated cleaning procedures (211.67), and stability program design (211.166).
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 Jiangmen Shuizirun Sanitary Articles Co., Ltd. MARCS-CMS 722974 — September 23, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE Reference #: 320-26-130 Product: Drugs Over-the-Counter Drugs Recipient: Recipient Name Mr. Huashen Liang Recipient Title General Manager Jiangmen Shuizirun Sanitary Articles Co., Ltd. Boyukou, Liangdechong Highway Sanjiangzhen Xinhui Qu Jiangmen Shi Guangdong Sheng , 529142 China Issuing Office: Center for Drug Evaluation and Research (CDER) United States September 23, 2026 WARNING LETTER Reference number: 320-26-130 To Mr. Huashen Liang: This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your facility. Promptly address the 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 that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory action without further notice. FDA Inspection Violations were observed and documented during an inspection of your drug manufacturing facility, Jiangmen Shuizirun Sanitary Articles Co., Ltd., FDA Establishment Identifier (FEI) 3014159182, at Boyukou, Liangdechong Highway, Sanjiangzhen Xinhui District Jiang Men, Guangdong, China, from November 3 to 7, 2025. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs. This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211). Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B). We reviewed your November 23, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Violations of the Federal Food, Drug, and Cosmetic Act The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility. 1. Failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile (21 CFR 211.113(b). Several of your (b)(4) (e.g., (b)(4) ) are labeled as “sterile.” We note that your OTC products including (b)(4) are not sterilized. In your response to our Form FDA 483, you stated, “Our (b)(4) are manu…
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 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 Jiangmen Shuizirun Sanitary Articles Co., Ltd. had FDA enforcement actions before?
- This is the only FDA Warning Letter Argus HQ has on file for Jiangmen Shuizirun Sanitary Articles Co., Ltd. as of 2026-10-13. Argus ingests new FDA enforcement records daily.
- What FDA violations was Jiangmen Shuizirun Sanitary Articles Co., Ltd. cited for?
- The FDA Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (issuing office: Center for Drug Evaluation and Research (CDER)) cites: CGMP/Finished Pharmaceuticals/Adulterated. Classification: CGMP — Current Good Manufacturing Practice.
- When did FDA issue the warning letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd.?
- FDA issued the letter (MARCS-CMS 722974) on 2026-09-23 and posted it publicly on fda.gov on 2026-10-13.
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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 Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (2026-09-23) — CGMP/Finished Pharmaceuticals/Adulterated. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/fda/warning-letter/fda-wl-jiangmen-shuizirun-sanitary-articles-co-ltd-2026-09-23-cgmp
"FDA Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (2026-09-23) — CGMP/Finished Pharmaceuticals/Adulterated." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/fda/warning-letter/fda-wl-jiangmen-shuizirun-sanitary-articles-co-ltd-2026-09-23-cgmp.
Argus HQ Research. "FDA Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (2026-09-23) — CGMP/Finished Pharmaceuticals/Adulterated." Digital Empire Holdings LLC. Accessed October 14, 2026. https://argushq.ai/fda/warning-letter/fda-wl-jiangmen-shuizirun-sanitary-articles-co-ltd-2026-09-23-cgmp.
@misc{argushq_argushq_ai_fda_warning_letter_fda_wl_jiangmen_shuizirun_sanitary_articles_co_ltd_2026_09_23_cgmp_2026,
title = {FDA Warning Letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. (2026-09-23) — CGMP/Finished Pharmaceuticals/Adulterated},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/fda/warning-letter/fda-wl-jiangmen-shuizirun-sanitary-articles-co-ltd-2026-09-23-cgmp},
note = {Accessed: October 14, 2026}
}