Jiangmen Shuizirun Sanitary Articles Co., Ltd. — FDA Warning Letter Findings

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure: Adequate documentation of production and process control functions executed at the time of performance (21 CFR 211.100(b)) Adequate validation of manufacturing processes and the (b)(4) system (21 CFR 211.100(a) Adequate written procedures for production and process control (21 CFR 211.100(a)) Adequate stability testing program (21 CFR 211.166) Adequate finished product testing (21 CFR 211.165(a), 211.165(b)) Your firm’s quality systems are inadequate. See FDA’s guidance document ICH Q10 Pharmaceutical Quality System, as well as Quality Systems Approach to Pharmaceutical CGMP Regulations, for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q10-pharmaceutical-quality-system and https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations, respectively. In response to this letter, provide: A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to: o A determination of whether procedures used by your firm are robust and appropriate o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices o A complete and final review of each batch and its related information before the QU disposition decision o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products Lot Identification CGMPs define a lot number, control number, or batch number as any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packing, holding, and distribution of a batch or lot of drug product or other material can be determined. Upon further review of your records and information, it appears that you assign the same batch number to different products fulfilled on a single Purchase Order. You have identified drug products with different active ingredients, routes of administration, use instructions, and dates of manufacture with the same batch number. You must establish written procedures to apply unique identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch. (21 CFR 211.130(c)). Drug Recall On February 3, 4, and 5, 2026, FDA attempted to contact you requesting a teleconference to discuss recalling your (b)(4) labeled as sterile, within expiry, and currently in distribution to the U.S. market. We have also attempted to contact your listed U.S. Agent. To date, neither you or your U.S. Agent have responded to any of our attempts for direct contact. We recommend you remove any batches of (b)(4) labeled as sterile currently in distribution and within expiry from the U.S. market. CGMP Consultant Recommended Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

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 manufactured under a controlled process designed to meet the microbial limits specified in the Certificate of Analysis (C of A).” Of note, your COA does not indicate your drugs are sterile, even though your labelling purports them to be so. Sterile (b)(4) may be used by (b)(4) , if labeled as sterile, must have controls in place to ensure sterility. The inspection documented that you do not perform sterility testing of the drug products at the time of release. Your Specification and Analysis Method on (b)(4) tests the Finished Product Quality Standards to the Chinese standard (b)(4) , with acceptance criteria of ≤ (b)(4) colony forming units (cfu)/gram of total aerobic bacteria, ≤ (b)(4) cfu/gram of mold and yeast, and no fecal coliforms. Your microbial count laboratory worksheet data for (b)(4) batch number (b)(4) , released (b)(4) , reported the presence of (b)(4) cfu/gram of total aerobic bacteria. This specification is unacceptable for drug products labeled sterile. Drugs purported to be sterile must comply with applicable 21 CFR 211 CGMP requirements including sterility assurance. In response to this letter, provide your action plan to address any product quality or patient safety risks for batches of your OTC drug products that are labeled as “sterile” and are in U.S. distribution, including potential customer notifications and recalls or market withdrawals.

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1), 211.84(d)(2) and 211.110(c)). You failed to perform adequate identity testing on each shipment of each lot of the incoming components (e.g., (b)(4) ) used in the manufacture of your OTC drug products. You also purchase (b)(4) multiple components used for manufacturing your drug products, some containing (b)(4) , and you do not test the in-process materials for identity, strength, quality, and purity as appropriate. For example, you did not ensure that each of the (b)(4) components met the relevant safety limits for (b)(4) . In both cases, you relied on your suppliers’ certificate of analysis without establishing the reliability of each of the suppliers’ test analyses at appropriate intervals. Identity testing for high-risk drug components (b)(4) includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for (b)(4) levels, respectively. Because you did not perform identity testing on each shipment of each lot using the USP identification test or an equivalent validated method that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products. (b)(4) You failed to adequately test each shipment of each lot of (b)(4) , used as an active pharmaceutical ingredient, for (b)(4) . The use of (b)(4) contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) . (b)(4) You failed to adequately test each shipment of each lot of (b)(4) , used as an inactive ingredient, for (b)(4) contamination. The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) In your response, you commit to updating the specification for every raw material used in US-bound OTC products to include at least one specific identity test. Your response is inadequate. You failed to specify the identity tests you intend to perform including limit tests to detect hazardous impurities as appropriate. Without adequate testing, you do not have appropriate assurance that components and purchased in process material (b)(4) , conform to appropriate specifications prior to use in the manufactured drug products. As a manufacturer, you have the responsibility to sample, test, and examine drug components and any purchased in-process material (b)(4) before use in production to assure adequate quality. In response to this letter, provide: A description of how you will test each component or purchased in-process material (b)(4) lot, for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s certificates of analysis (COA) instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4) and certain additional high-risk components we note that this includes the performance of (b)(4) of the United States Pharmacopeia (USP) monograph. A commitment to provide (b)(4) test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of (b)(4) . A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4) ). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4) , including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter. The chemical and microbiological quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing. A comprehensive assessment of your in-process monitoring and sampling operations, focusing on each upstream process step that can introduce variability. Provide your remediation plan to improve: (1) in-process detection of variation, (2) upstream controls, and (3) sampling plans. A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures. A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your SOP that describes this COA validation program. A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.