Delivery Method:VIA UPSReference #:320-25-69Product:DrugsRecipient:Mr. David DuanGeneral ManagerNingbo Riway Industrial Co., Ltd.No. 555 Binhai Avenue Building E1, Binhai Wanyang Creative CityBinhai New Area, Economic Development ZoneFenghua ShiNingbo ShiZhejiang Sheng,315524ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-69April 30, 2025Dear Mr. Duan:Your facility is registered with the United States Food and Drug Administration (FDA) as a manufacturer of over-the-counter (OTC) drug products. FDA has reviewed the records you submitted in response to our March 11, 2024 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic (FD&C) Act for your facility, Ningo Riway Industrial Co., Ltd., FEI 3016905536, at No. 555 Binhai Avenue, Building E1, Binhai Wanyang Creative City, Binhai New Area, Economic Development Zone, Fenghua District, Ningbo, Zhejiang.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations, parts 210 and 211 (21 CFR, parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding of drugs as described in your response to our 704(a)(4) request do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)).Unapproved New Drug and Misbranded Drug ViolationsIn addition, KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), 331(d). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of misbranded products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). These violations are described in more detail below.704(a)(4) Request for Records and Related CGMP ViolationsFollowing review of records and other information provided pursuant to section 704(a)(4) of the FD&C Act, significant violations were observed including, but not limited to, the following:1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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) and 211.84(d)(2)).Your firm manufactures OTC drug products, including antimicrobial hand wipes. Based on the records and information you provided, you did not demonstrate that you adequately tested the identity of incoming components (e.g.,(b)(4)and isopropyl alcohol) used in the manufacture of your drug products. You also accept your suppliers’ certificates of analyses (COAs) without verifying the test results at appropriate intervals. In your response, while you state that you review the COA of your components, you did not state that you test your incoming components, including to perform(b)(4)limit testing for your(b)(4)or methanol for isopropyl alcohol (IPA) components.(b)(4)Identity testing for(b)(4)and certain other high-risk drug components include a limit test in the United States Pharmacopeia (USP) to ensure that the component meets the relevant safety limits for levels of(b)(4). Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to assure the acceptability of these components for use in the manufacture of your drug products.The use of ingredients contaminated with(b)(4)has resulted in various lethal poisoning(b)(4)to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for(b)(4)contamination at(b)(4).Isopropyl AlcoholYou failed to adequately test your incoming IPA, which is used as an active ingredient, for methanol. The use of IPA contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance documentPolicy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanolto help you meet the CGMP requirements when manufacturing drugs containing IPA at https://www.fda.gov/media/173005/download.Without adequate testing, you do not have scientific evidence that your components conform to appropriate specifications prior to use in the manufacture of your drug products.2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Based on the records and information you provided, you did not demonstrate that you adequately tested your finished drug products prior to release and distribution. For example, the test reports that you provided in your response, did not include an appropriate assay test for active ingredient content or impurities. Additionally, the records you provided did not contain adequate microbiological tests as some of the products you manufacture are labeled as sterile. Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity and strength of the active ingredient, prior to release and distribution. Without adequate testing, you do not have scientific evidence to assure that your drug products conform to appropriate specifications before release.3. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. For example, your QU failed to ensure that your water system used in the manufacture of your OTC sterile IPA prep pads, is appropriately designed and monitored, and to adequately exercise its authority in the approval or rejection of components in your Materials System.Your QU is responsible for fully exercising its authority and responsibilities. FDA is concerned that your QU may not be conducting appropriate oversight regarding CGMP operations.See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor 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/media/71023/download.CGMP Consultant RecommendedBased 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 if your firm intends to resume manufacturing drugs for the U.S. market. 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.Unapproved New Drug and Misbranded Drug ViolationsYour KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES products are drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body.Examples of claims observed on the KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES product labels provide evidence of the intended use (as defined in 21 CFR 201.128) of the products include, but may not be limited to, the following:KLEAN FREAK BODY WIPE“DRUG FACTS” ; “Purpose Antibacterial” ; “Use: To decrease bacteria on the skin.” [from product label]JJ CARE ADHESIVE REMOVER WIPES“DRUG FACTS” ; “Purpose Antiseptic” [from product label]Unapproved New Drug ViolationsBased on the above labeling evidence, KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES are intended for use as topical antiseptic drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 USC 355(a) and 331(d).A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products, nor are we aware of any adequate and well-controlled clinical studies in the published literature that support a determination that your KLEAN FREAK BODY WIPE or JJ CARE ADHESIVE REMOVER WIPES drug products are GRASE for use under the conditions suggested, recommended, or prescribed in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order under section 505G(b). Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).KLEAN FREAK BODY WIPEOver-the-counter (OTC) topical antiseptic products had been the subject of rulemakings under the Agency’s OTC Drug Review. In particular, such products were addressed in a tentative final monograph (TFM) entitled “Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Tentative Final Monograph for Health-Care Antiseptic Drug Products,” Proposed Rule, 59 FR 31402 (June 17, 1994) (1994 TFM), as further amended by “Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 81 FR 42912 (June 30, 2016) (Consumer Antiseptic Rubs Proposed Rule).Over the course of these rulemakings, three active ingredients (benzalkonium chloride, ethyl alcohol (ethanol), and isopropyl alcohol) were classified as Category III for use in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub. Additionally, health care topical antiseptics were addressed in the 1994 TFM, as further amended by “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record,” Proposed Rule, 80 FR 25166 (May 1, 2015) (Health Care Antiseptics Proposed Rule), and “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,” Final Rule, 82 FR 60474 (December 20, 2017) (Health Care Antiseptics Final Rule). Over the course of these rulemakings, six active ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethyl alcohol, isopropyl alcohol, and povidone-iodine) were classified as Category III for use in health care antiseptic products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a health care antiseptic, including for use as a patient antiseptic skin preparation.Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as “over-the-counter (OTC) monograph drugs”—may be legally marketed if they meet applicable requirements.Under section 505G(a)(3), drugs that were classified as Category III for safety or effectiveness in a TFM that is the most recently applicable proposal or determination for a drug issued under 21 CFR Part 330 – and that were not classified as Category II for safety or effectiveness – are not required to have an approved application under section 505 in order to be marketed, as long as they meet the relevant conditions outlined in the applicable TFM, including the active ingredient, and comply with all other applicable requirements.Your KLEAN FREAK BODY WIPE product does not conform to the 1994 TFM, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.As labeled, your product KLEAN FREAK BODY WIPE includes an intended use beyond what is permitted in the applicable rulemaking for consumer antiseptic rub products. Specifically, the label includes the description “Body Wipe,” and the “Directions” section of the product label includes the statement, “…wipe down that dirty body…yep…even all those nooks and crannies.” The monograph conditions of use for consumer antiseptic rubs set forth in the rulemakings described above limit the use of the product to the hands and do not include application to the whole body. Therefore, your product does not conform to the TFM or the applicable requirements and goes beyond describing the intended use of consumer antiseptic rub products as set forth in the 1994 TFM and amended by the 2016 Consumer Antiseptic Rubs Proposed Rule.1The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).JJ CARE ADHESIVE REMOVER WIPESAs labeled, JJ CARE ADHESIVE REMOVER WIPES is intended for use as a topical antiseptic drug product and contains the active ingredient “Isopropyl Alcohol 1%.” However, this product does not meet the conditions under section 505G of the FD&C Act for marketing without an approved application under section 505, whether as a consumer or healthcare antiseptic rub or as a first aid antiseptic. JJ CARE ADHESIVE REMOVER WIPES’ labeled concentration of isopropyl alcohol is less than the required concentration of 70 to 91.3 percent for this active ingredient for either a consumer or healthcare antiseptic rub product. Your JJ CARE ADHESIVE REMOVER WIPES product therefore does not conform to the 1994 TFM, nor any other TFM, proposed rule, or final rule, and does not meet the conditions under section 505G(a)(3) of the FD&C Act for marketing without an approved application under section 505.Likewise, JJ CARE ADHESIVE REMOVER WIPES does not conform to the conditions in Over-the-Counter Monograph M003: First Aid Antiseptic Drug Products for Over-the-Counter Human Use (henceforth “M003”). Under section 505G(a)(1), a nonprescription first aid antiseptic drug product, in order to be GRASE and not a new drug must, among other things, conform to the conditions in the applicable OTC monograph, here M003. However, JJ CARE ADHESIVE REMOVER WIPES’ labeled concentration of isopropyl alcohol is less than the required concentration of 50 to 91.3% by volume in an aqueous solution for this active ingredient, as specified in M003. Thus, JJ CARE ADHESIVE REMOVER WIPES do not comply with the applicable conditions specified in M003. Because this product has not otherwise been found GRASE, it is a new drug within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis for marketing it without an approved application under section 505G of the FD&C Act. Because there is no approved application in effect for this product, it is an unapproved new drug. The introduction or delivery for introduction of this unapproved new drug product into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).Misbranded Drug ViolationsThe products KLEAN FREAK BODY WIPE and JJ CARE ADHESIVE REMOVER WIPES are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed your firm on Import Alert 66-40 on November 7, 2024.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Ningo Riway Industrial Co., Ltd., FEI 3016905536, No. 555 Binhai Avenue, Building E1, Binhai Wanyang Creative City, Binhai New Area, Economic Development Zone, Fenghua District, Ningbo, Zhejiang, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated or misbranded may be detained or refused admission.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3016905536 and ATTN: Daniel W. Brisker.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research/S/Tina SmithCaptain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchCC:Registered U.S. AgentJake SztejmanPresidentPro Medical Supplies Inc.Jake.sztejman@outlook.com__________________________1The 2015 Health Care Antiseptics Proposed Rule covered health care antiseptic products intended for use without water. Under the 1994 TFM, as amended by the 2015 Health Care Antiseptics Proposed Rule and 2017 Health Care Antiseptics Final Rule, certain health care topical antiseptic products intended for use without water, including patient antiseptic skin preparations, are permitted. Your KLEAN FREAK BODY WIPE product does not meet the monograph conditions of use for OTC patient antiseptic skin preparation products, as set forth in the healthcare topical antiseptic rulemakings described above, including because its labeling does not include directions for use as a patient antiseptic skin preparation.

Delivery Method:VIA UPSReference #:320-25-66Product:DrugsRecipient:Mr. WuXiong WuGeneral ManagerShantou S.E.Z. Baojie Industry Co., Ltd.Sihuang Road Lugang TownChaonan QuShantou ShiGuangdong Sheng,515144ChinaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-66April 15, 2025Dear Mr. Wu:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Shantou S.E.Z. Baojie Industry Co., Ltd., FEI 3016787260, at Sihuang Road Lugang Town, Chaonan District, Shantou, Guangdong, China, from August 26 to 30, 2024.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 September 11, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. 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) and 211.84(d)(2)).Your firm manufactures over-the-counter (OTC)(b)(4)drug products without adequate assurance of the quality of components used in their manufacture. For example, you failed to adequately test your incoming components, including identity testing for each shipment of each component lot used in the manufacture of your OTC drug products. Instead, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals. Additionally, your firm failed to test a representative sample from each shipment of each lot of high-risk components used in your drug products.Of note, after FDA sent an electronic request 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), on October 2, 2023, you committed to performing identity testing on every lot of high-risk components and every batch of finished products. However, during the inspection, and despite previous commitments, you failed to adequately test your incoming high-risk components for contamination.In your response to the Form FDA 483 issued to your firm after the August 2024 inspection, you state that you would contact your third-party laboratory to retest(b)(4)and(b)(4), and include identity testing of your raw materials, including(b)(4). Your response is inadequate. You failed to provide sufficient details on how you will ensure adequate identity testing of a representative sample from each lot of(b)(4). Further, you do not address potential impact on drug products in the U.S. market within expiry. FDA is also concerned that you had committed to corrections previously but did not implement them.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to ensure adequate quality.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)to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for(b)(4)contamination at(b)(4).In response to this letter, provide:The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure that describes this COA validation program.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 your program for qualifying and overseeing contract facilities that test the drug products you manufacture.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 action and preventive action (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.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s 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 revalidation. 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 parts A, B, and C of the United States Pharmacopeia (USP) monograph.2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).You use(b)(4)as a component in your drug products and for cleaning production equipment. However, you have not established that the(b)(4)system is adequately designed, maintained, and monitored to ensure that it consistently produces(b)(4)suitable for its intended use. You also lacked appropriate testing of your(b)(4)system, and your sampling frequency is not representative of actual use.In your response, you state that you would re-evaluate the qualification of your(b)(4)system. Your response is inadequate. You failed to provide an assessment of the impact your(b)(4)system has on your drug products in the U.S. market within expiry.The lack of data regarding the state of control of your(b)(4)system poses a potential risk for objectionable microbiological contamination into your drug products.(b)(4)must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate chemical and microbiological attributes.In response to this letter, provide:A comprehensive remediation plan for the design, control, and maintenance of the(b)(4)system, including a robust monitoring program.A(b)(4)system validation report, along with a summary of any improvements made to the system design and the ongoing control and maintenance program.Your total microbial count limits to monitor whether this system is producing(b)(4)suitable for the intended uses for each of your products.A procedure for your(b)(4)system monitoring that specifies routine microbial testing of(b)(4)to ensure its acceptability for use in each batch of drug products produced by your firm.3. Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).You did not have adequate stability data to demonstrate that the quality attributes of your drug product remain acceptable throughout the labeled expiry period. For example, your stability testing procedure only requires an organoleptic assessment (odor, color, appearance) and lacks chemical and microbial analysis. Without appropriate stability studies, there is no scientific evidence to support that your drug products retain their quality attributes through the labeled(b)(4)expiry.In your response, you state that you plan to revise your firm’s procedure to clarify that the stability test time for finished products will be 30 days, and for new products, it will be 6 months. Your response is inadequate. You failed to provide an assessment on the potential impact of your drug products in the U.S. market within expiry, a scientific rationale for the proposed revisions to your stability testing procedure to support the labeled expiry, and a commitment for ongoing stability studies.In response to this letter, provide:A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.4. 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 provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following:Adequate testing of your incoming components for identity, purity, strength, and other appropriate quality attributes (21 CFR 211.84(d)(1) and 211.84(d)(2)).Establishment of written procedures for production and process controls (21 CFR 211.100(a)).Establishment of an adequate, ongoing stability program (21 CFR 211.166(a)).Establishment of a procedure and for the performance of appropriate product reviews (21 CFR 211.180(e)(1)).Verification of testing methods to ensure accurate, precise, and reliable results (21 CFR 211.194(a)(2)).As part of your response, you state that you are “unfamiliar with FDA standards”, even though you have a history of distributing drugs to the United States. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor 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/media/71023/download.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.CGMP Consultant RecommendedBased 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 if your firm intends to resume manufacturing drugs for the U.S. market. 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 CAPA 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.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on April 9, 2025.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Shantou S.E.Z. Baojie Industry Co., Ltd., Sihuang Road Lugang Town, Chaonan District, Shantou, Guangdong, China, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated [or misbranded] may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3016787260 and ATTN: Kevin Maguire.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and ResearchCc:Registered U.S. Agent:Panatural USA, Inc.Sol Great Labs3705 W. Pico Blvd.Suite 1766Los Angeles, CA 90019-3451peter@panaturalusa.comruss@thesourcingsolution.com

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-67Product:DrugsRecipient:Mr. Arvind NandaJoint Managing DirectorMentha & Allied Products Private Ltd.16th Km Rampur-Swar RoadRampur244901Uttar PradeshIndiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-67April 16, 2025Dear Mr. Nanda:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Mentha & Allied Products Private Ltd., FEI 3004293613, located at 16th Km Rampur-Swar Road, Rampur, Uttar Pradesh, India, from September 16 to 25, 2024.This warning letter summarizes significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API is 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 December 10, 2024 response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigators observed specific deviations including, but not limited to, the following.1. Failure to properly maintain buildings and facilities used in the manufacture of API.Facility ConditionsYou failed to maintain your drug manufacturing facility in a good state of repair. The washroom used by operators was observed to be heavily soiled, and soap for handwashing was not available. In addition, the gowning room was observed to have dirty lockers, garments, and operator shoes. Visibly soiled cloth gloves, which come into direct product contact with the(b)(4)USP(b)(4)API, were also observed in a supervisor’s desk drawer to be used by operators during manufacturing. You reported that these gloves are cleaned after use; however, you lacked documentation to support their cleaning.Equipment Cleaning and MaintenanceYou failed to have adequate procedures for cleaning and maintenance of manufacturing equipment. For example, our investigators observed manufacturing equipment labeled as “cleaned” but found with the following deficiencies.A(b)(4)was labeled as clean and ready to be used; however, it was observed with residual product and a fraying rope inside the(b)(4).A(b)(4)and(b)(4)were identified as cleaned; however, a significant amount of(b)(4)was observed on both pieces of equipment.Equipment and utensils (e.g.,(b)(4)and(b)(4)), used to(b)(4)the(b)(4)USP(b)(4)API, were found to be stored on a dirty(b)(4)during the manufacturing of lot(b)(4).(b)(4)were observed to be unclean, and these units lacked documentation of cleaning activities.You also failed to adequately document and validate cleaning procedures. For example, your cleaning validation lacked details of the cleaning process (e.g., use of solvent or detergent, and description of critical cleaning steps). Sampling performed for microbial residues was identified to be from “different places” on the equipment and lacked specific sample locations and scientific rationale for their selection. In addition, you did not adequately document your equipment cleaning as part of the batch record or a cleaning record.It is essential that your facility is in a good state of repair and sanitary conditions are maintained to avoid product contamination. Inadequately cleaned and maintained manufacturing equipment can lead to potential cross-contamination that could compromise your API’s quality and safety.In response to this letter, provide:Your corrective action and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Your plan should also ensure equipment is suitable for its intended use.A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices and encompass each piece of manufacturing equipment used to manufacture intermediates and API products.2. Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.Poor Documentation PracticesYour firm manufactures(b)(4)USP(b)(4)API. Your quality unit (QU) failed to implement adequate controls to ensure the integrity of data generated at your facility. Our investigators observed unacceptable documentation practices, including, but not limited to, the following: torn batch records, a torn testing chromatogram found in the manufacturing area uncontrolled labeling and clearance forms in the packaging area, and a partially completed labeling and clearance form in an unlocked desk drawer.In addition, manufacturing batch records were initiated after the(b)(4)stage of the crude(b)(4)was completed. Your operators’ practice was to backfill data that had previously been recorded on uncontrolled sheets for this initial API processing stage. These uncontrolled sheets were not maintained.CGMP activities must be documented at the time of performance. Non-contemporaneous documentation on manufacturing records raises concerns about the validity and integrity of your firm’s documentation practices and records.Inadequate Electronic Data ControlsYou failed to follow adequate controls for your computerized systems. For example, your computerized data backup procedure states that data is(b)(4)archived to a cloud server; however, data from the Agilent OpenLab Chromatographic Data System (CDS) was instead being archived(b)(4)to a second hard drive on the same computer. During the inspection, our investigators documented that the second hard drive was corrupted, and chromatographic data, obtained from February to September 2024, may have been affected.You provided a document stating that the hard drive was sent to an external contractor for data recovery; however, you did not conduct a thorough investigation into this incident. Additionally, you failed to identify the specific data that may have been affected, including an evaluation of the potential impact on product quality.Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance documentData Integrity and Compliance With Drug CGMPfor guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.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.A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global CAPA plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.3. Failure to test the identity of each batch of incoming production material and to appropriately qualify suppliers to rely upon their certificate of analysis.You failed to conduct an identity test on each lot of raw material used in the manufacture of your API. You instead relied on the certificates of analysis (COAs) from your suppliers without adequately qualifying them. You tested(b)(4), received as your primary raw material, for some quality attributes; however, an identity test was not performed before use in manufacturing.In addition, your procedure for vendor qualification states that critical vendors, such as suppliers of active raw materials, are required to be qualified. You did not qualify your suppliers of primary raw material and failed to establish the reliability of each of your suppliers’ COA for raw material specifications and characteristics.Without adequate testing, there is no scientific evidence to assure that your raw materials conform to appropriate specifications before release.In response to this letter, provide a comprehensive review of your material system to determine whether all suppliers of raw materials 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 raw materials.4. Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality.Inadequate Testing of(b)(4)APIYou failed to adequately test your(b)(4)USP(b)(4)API per the current USP monograph. For example, you did not conduct testing for “(b)(4)” and “(b)(4).” These tests are not required in your API specification. As a result, you distributed lots of(b)(4)API to the U.S. market without assurance that they meet the current USP standards. This may also render your(b)(4)USP adulterated under section 501(b) of the FD&C Act.Inadequate Method VerificationYou failed to perform an adequate analytical method verification for(b)(4)assay. Your protocol did not include an acceptance limit for the verification of the precision (percent relative standard deviation). The verification exercise included a single determination of each test.Inadequate Stability Method ValidationYou failed to ensure that the analytical method used for stability testing of(b)(4)USP(b)(4)API is suitable for its intended use. For example, you did not perform forced degradation studies to demonstrate that the method is stability-indicating.In response to this letter, provide:A comprehensive assessment of your laboratory practices, procedures, methods, equipment, and documentation. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.A list of chemical and microbial test methods and specifications used to analyze each lot of your drug product before making a lot disposition decision, and the associated written procedures.A comprehensive assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).5. Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.Inadequate Process ValidationYou failed to adequately validate your(b)(4)API manufacturing process. For example, your process validation lacked a scientific rationale for not including the smallest batch size your firm manufactures, a defined sampling plan for each stage, and testing requirements for raw materials used. In addition, your report lacked an evaluation of critical processing parameters results for the validation batches.Equipment QualificationYou lacked qualification for major equipment, such as the(b)(4)tank,(b)(4)machine, and(b)(4). In addition, the qualification of the(b)(4)lacked testing of the(b)(4)response to different types of metal, evaluation of its sensitivity to different sizes and types of(b)(4)particles, functionality of rejection mechanisms, and evaluation of operating conditions for different flow rates or product throughput. Furthermore, the qualification of the(b)(4)lacked a comprehensive range of operating parameters.Without adequate process validation, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications. See FDA's guidance for industry,Process Validation: General Principles and Practicesfor general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. Adequate and complete equipment qualification is also critical to ensure process performance.In response to this letter, provide your validation protocols and reports and critical equipment qualification protocols and reports. Also provide an update on the status of process performance qualification for your manufacturing processes for(b)(4)API for further distribution to the U.S. market and your program for ensuring an ongoing state of control of yourmanufacturing processes.CGMP Consultant RecommendedBased upon the nature of the deviations we identified at your firm, you should engage a consultant qualified to evaluate your operations to assist your firm in meeting CGMP requirements.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.Cosmetics Manufactured for Distribution in the United StatesIn addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. A cosmetic is deemed adulterated under section 601(c) of the FD&C Act [21 U.S.C. 361(c)] if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health. Some conditions that cause the drug products you manufacture to be adulterated may also cause any cosmetics you manufacture to be adulterated. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated. Further, your facility may be subject to requirements under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at https://www.fda.gov/cosmetics/cosmetics-guidance-regulation/cosmetics-guidance-documents.ConclusionThe deviations cited in this letter are not intended to be an all-inclusive list of deviations that exist at your facility. You are responsible for investigating and determining the causes of any deviations and for preventing their recurrence or the occurrence of other deviations.Correct any deviations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any deviations.Failure to address any deviations may also result in the FDA refusing admission of articles manufactured at Mentha and Allied Products Private Ltd., 16th Km Rampur-Swar Road, Uttar Pradesh, Rampur, India, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any deviations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3004293613 and ATTN: Vilmary Negrón Rodríguez.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Delivery Method:VIA UPSReference #:320-25-57Product:DrugsRecipient:Mr. Kee Pee HoManaging DirectorBioAsia Worldwide Sdn BhdH-G-01 & H-01-01 Block H – Sekitar 26Persiaran Hulu Selangor, HICOM Industrial Estate, Seksyen 2640400Shah AlamSelangorMalaysiaIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-57March 25, 2025Dear Mr. Ho:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, BioAsia Worldwide Sdn Bhd, FEI 3015509166, located at U-11, Lumut Port Industrial Park, Mukim Lumut, Sitiawan, Perak from October 14 to 17, 2024.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 4, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP.During our inspection, our investigator observed specific violations including, but not limited to, the following.1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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) and 21 CFR 211.84 (d)(2)).Your firm contract manufactures over-the-counter (OTC)(b)(4)drug products, including(b)(4)and(b)(4). You failed to perform adequate identity testing of each component lot used in the manufacture of these drug products. You also relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals. Furthermore, you failed to demonstrate that the component(b)(4), used to manufacture your drug product(b)(4), meets United States Pharmacopoeia (USP) specifications.In your response, you state identity testing and verification of the supplier’s COA will be performed. Your response is inadequate because you did not provide adequate details of your supplier qualification program and how you will ensure appropriate incoming testing will be performed for each component. Additionally, you did not propose testing retain samples or otherwise conduct an analysis of previously used drug product components to ensure all quality attributes were met.Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications before use in the manufacture of your drug products. You have a responsibility to sample, test, and examine drug components before use in production to ensure acceptable quality parameters are met.In response to this letter, provide:A comprehensive 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.The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COAs 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.A summary of results obtained from testing all components to evaluate the reliability of the COA from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.2. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).Your firm failed to perform appropriate testing on your drug products prior to release for distribution. For example, you rely on physical and organoleptic testing, such as appearance and odor. Furthermore, you failed to perform adequate testing on(b)(4)and(b)(4)to demonstrate appropriate strength for(b)(4)and(b)(4), respectively, prior to release.In your response, you state that each batch of finished(b)(4)will be tested for assay. Your response is inadequate because you did not provide sufficient details regarding the analytical methods that will be used. Additionally, you failed to provide a plan to test retain samples of finished drug products to ensure all quality attributes were met.Furthermore, in your response, you commit to performing microbiological testing of your drug products. Your response is inadequate because you did not propose to perform method validation nor state whether you intend to follow USP test methods. You did not provide sufficient information to demonstrate that your methods are equivalent to or better than the applicable USP compendial methods and suitable for their intended use.Drug product batches must be tested for identity, strength, quality, and purity prior to release. Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use, including microbiological specifications. Without adequate testing, you lack scientific data to support that each drug product batch conforms to appropriate specifications before release.In response to this letter, provide:A list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.A comprehensive, independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.3. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)).Your firm failed to conduct adequate stability studies on the OTC drug products,(b)(4)and(b)(4). For example, your stability program did not include full shelf-life studies evaluating the OTC drug products for the entire length of your established expiry dates. In addition, your accelerated stability study did not include testing for strength at any time point. Furthermore, no scientific data was provided to support that a 90-day accelerated study can justify a(b)(4)expiration for the(b)(4).In your response, you state that you will begin stability studies. Your response is inadequate because it lacks sufficient detail describing your stability program procedures and protocols.Without an adequate stability program, you cannot confirm that your drug products will meet established specifications and all pre-determined quality criteria throughout their shelf life.In response to this letter, provide:A comprehensive assessment and corrective action and preventive action (CAPA) plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:o Stability indicating methods.o Stability studies for each drug product in its marketed container-closure system before distribution is permitted.o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid.o Detailed definition of the specific attributes to be tested at each station (timepoint).All procedures that describe these and other elements of your remediated stability program.4. Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).Your firm failed to validate your manufacturing processes for your OTC drug products. Your firm also failed to qualify equipment and validate your cleaning processes for non-dedicated equipment used to manufacture your OTC drug products.In your response, you state that your firm is working on creating a master validation plan, qualification plan, and a cleaning validation document. Your response is inadequate because you have not provided details on performing process validation studies for each OTC drug product or your equipment qualification plans. You also did not provide a protocol driven cleaning validation study.Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies determine whether an initial state of control has been established. Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure that you maintain a stable manufacturing operation throughout the product lifecycle.Without adequate process validation, incorporating all manufacturing inputs and parameters that can affect product quality, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications. See FDA's guidance for industry,Process Validation: General Principles and Practicesfor general principles and approaches that the FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.In response to this letter, provide:A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.A timeline for performing appropriate PPQ for each of your marketed drug products.Process performance protocol(s), and written procedures for qualification of equipment and facilities.A detailed program for designing, validating, maintaining, controlling, and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst-case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:o Drugs with higher toxicitieso Drugs with higher drug potencieso Drugs of lower solubility in their cleaning solventso Drugs with characteristics that make them difficult to cleano Swabbing locations for areas that are most difficult to cleano Maximum hold times before cleaningIn addition, describe the steps that must be taken in your change management system before introduction of new manufacturing equipment or a new product.A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.5. 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) failed to perform adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure the following:Establishment of an adequate training program (21 CFR 211.25(a))Performance of appropriate product reviews (21 CFR 211.180(e))In your response, you state that your employees will be trained in 21 CFR 210 and 211(b)(4). Your response is inadequate because you do not provide sufficient details on how your staff will be trained in 21 CFR 210 and 211 regulations. Additionally, you did not address completing product reviews retrospectively.An adequate QU overseeing all CGMP operations is necessary to ensure consistent drug quality. See FDA’s guidance documentQuality Systems Approach to Pharmaceutical CGMP Regulationsfor 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/media/71023/download.CGMP Consultant RecommendedBased 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 audit1of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs 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.Cosmetics Manufactured for Distribution in the United StatesIn addition, we note that some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. Under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded.Further, your facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Information on MoCRA requirements may be found at https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on February 20, 2025.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at BioAsia Worldwide Sdn Bhd, U-11, Lumut Port Industrial Park, Mukim Lumut, Sitiawan, Perak 32000, Malaysia, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3015509166 and ATTN: Barbara Wilimczyk-Macri.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research______________________1i.e., Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.

Delivery Method:VIA EMAIL WITH READ RECEIPTReference #:320-25-70Product:DrugsRecipient:Mr. Bernard FraissePresident & CEOExcelvision Fareva32 Pl. de la Gare, 1616GareLuxembourgFranceIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-70May 7, 2025Dear Mr. Fraisse:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Excelvision, FEI 3007058211, at 27 Rue de la Lombardiere, Annonay, Ardeche, France, from November 12 to 19, 2024.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 December 10, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).You failed to adequately investigate customer complaints for the various sterile(b)(4)drug products (prescription and over-the-counter) you manufacture. Your investigations were not thorough, did not appropriately expand in scope, and lacked a scientifically supported determination of root cause(s). Additionally, they failed to include an evaluation of customer complaint samples from the affected batches. You did not identify or implement adequate corrective actions and preventive actions (CAPAs).Specifically, between January 2023 and November 2024, you received multiple complaints related to the presence of mold, black specks, and discoloration on the(b)(4), and inside the product container of your(b)(4)drug products. Without supporting evidence, you attributed the root causes to the inadequate handling by customers who used your products (i.e., complainant leaving product residues in the container closure system) and determined that no further action was necessary.In August 2024, environmental sampling of Room(b)(4), corridor(b)(4), and(b)(4)revealed the presence ofPenicillium citrinum, Fusarium oxysporum, andAspergillusmold species, respectively. On September 25, 2024, during environmental monitoring, an operator involved in the installation of the(b)(4)inside the ISO 5 (Grade A) of the additional(b)(4)filling line tested positive forPenicillium citrinummold species on their right glove. Your investigation documented that water was found underneath the(b)(4)floor in the compounding tank in room(b)(4), which is used to manufacture sterile(b)(4)drug. You attributed the root cause of the mold excursions in the building(b)(4)to the water leaks discovered. On November 8, 2024, and as a corrective action to mold detection, the floors were replaced with a new(b)(4).Notably, you had recovered mold species such asAspergillus(July 13, 2022, filling room(b)(4)),Zygomycete(March 9, 2022, filling room(b)(4)), andPenicillin(November 2, 2022, filling room(b)(4)) in the building(b)(4). However, as part of the investigations, you failed to consider the presence of mold in the ISO7 (Grade B) manufacturing areas over a 3-year period.The presence of mold, black specks, and discoloration in(b)(4)drug products presents serious risks to consumers, especially since these are sterile products intended for(b)(4)application. Furthermore, the documented history of mold recovery in the aseptic filling lines and water leaks in the compounding room suggests a persistent environmental control issue that, if left unaddressed, compromises the sterility and safety of your drug products. It also indicates that your CAPAs have been ineffective to eliminate the present of mold in your manufacturing areas.In your response, you state that the standard operating procedure has been revised to include a “questionnaire” for customers related to microbial contamination, as well as a new indicator to require microbial determination and sterility test for all returned samples. Additionally, you indicate that you will update your procedure for all returned and retained samples related to potential microbial contamination that will be sent to the microbiology laboratory for further examination. Also, the procedure will include genetic identification (i.e., genus and species) of molds to be performed on return samples and compare with mold identified in filling areas.Your response is inadequate. It fails to provide a comprehensive investigation into the customer complaints related to mold and black speck samples deviations. Additionally, you did not extend your investigations to other batches to determine the full scope and impact of the deviations on the product. In addition, you have not implemented an effective CAPA plan for the complaint investigations to prevent reoccurrence. You have not indicated whether the mold excursions in the aseptic filling lines have been corrected.In response to this letter, provide the following:A comprehensive, independent assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality assurance unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates if staff with proper investigation competencies effectively conducts root cause analysis, assures CAPA effectiveness, regularly reviews investigations trends, implements improvements to the CAPA program when needed, ensures appropriate quality assurance unit decision rights, and is fully supported by executive management.A management strategy including the interim measures describing the actions you have taken to ensure the safety and quality of your drugs currently in the market, such as notifying customers, recalling potentially affected drug products, conducting additional testing, adding batches to your stability program, and enhancements to your complaint system.For your(b)(4)container closure system(b)(4)drug products, provide your risk assessment for the current container closure system (i.e.,(b)(4)) that describes the effectiveness of the(b)(4)mechanism. Also, we recommend that you conduct your own testing to determine the effectiveness of your CCS in preserving the sterility of drugs in products.2. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).Your air flow visualization studies (i.e., smoke studies) performed for your ISO 5 (Grade A)(b)(4)traditional aseptic filling line, used to fill(b)(4)drug products for the U.S. market, did not demonstrate unidirectional airflow. For example, airflow was observed to swirl, stagnate, and move sideways and upward toward the air return vent in the ceiling of the room when the(b)(4)of the(b)(4)filling line was(b)(4)to Room(b)(4)to introduce materials.Additionally, our investigators observed various instances of poor aseptic techniques during a manual intervention, specifically when connecting the(b)(4)in the ISO 5 (Grade A) filling line. Also, operators leaned against or blocked the first air inside the line and extended their non-sanitized forearms near the(b)(4), where the product bottles are open.The ISO 5 (Grade A) area is critical because sterile products are exposed and therefore vulnerable to contamination. Your aseptic manufacturing process should be designed, and operations executed, to prevent contamination hazards to your sterile product. Flaws in the design of cleanrooms and aseptic processing lines, or improper execution of aseptic operations, can promote influx of contamination into the critical processing area.In your response, you acknowledge the deficiencies on the air flow visualization and concur with the risk associated to drugs with the manual aseptic practices and thus will implement training and update procedures. You commit to perform new air flow visualizations in the filling lines. Also, to implement the use of long gloves (able to sanitize wrists and forearms) before ISO 5 (Grade A) interventions and(b)(4)operator to support interventions.Your response is inadequate. You do not clearly specify how you will improve your air flow visualization, interventions in your ISO5 area, and how you intend to address potential deficiencies. Without adequate smoke studies, you cannot substantively assess whether your unidirectional airflow in the ISO 5 (Grade A) area protects the sterile drug products. Your response does not sufficiently address the lack of oversight of aseptic behavior of operators. Further, you do not adequately investigate poor aseptic practices to determine the impact on sterile drug products manufactured and aseptic processing areas.In response to this letter, provide the following:Smoke studies under dynamic conditions, with thorough and complete evaluations of aseptic interventions and operator positioning within the critical filling areas. After you remediate your aseptic operation, provide smoke studies that visualize airflow and critically evaluate unidirectional airflow. Include a video of your dynamic smoke studies.A comprehensive risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including an independent assessment that includes, but is not limited to:o All human interactions within the ISO 5 areao Equipment placement and ergonomicso Air quality in the ISO 5 area and surrounding roomo Facility layouto Personnel flows and material flows throughout all rooms used to conduct and support sterile operations.o Building management systems (e.g., address insufficiencies in differential pressure recording frequency)A detailed remediation plan based on review and recommendations by a qualified third party with specific expertise in aseptic processes, with timelines, to address the findings of the contamination hazards risk assessment. Describe how you will significantly improve aseptic processing operation design and control. Include comprehensive improvements in the design of both your aseptic processing lines and cleanrooms. Also describe your plans for qualification and validation of your extensively remediated operations.3. Your firm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions and an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(v) and 211.42(c)(10)(vi)).Your aseptic processing operation is inadequately designed to prevent contamination of your sterile(b)(4)drug products. For example, the(b)(4)product ISO 5 (Grade A) filling line(b)(4), is cleaned and sanitized using(b)(4). However, critical equipment components, such as bowls and(b)(4)are not sterilized prior to installation and setup of the filling line. You rely on swab samples taken from equipment surfaces to determine whether the filling line has been properly cleaned and sanitized.Additionally, during the current inspection, scratch marks were observed on the(b)(4)of the(b)(4)aseptic filling line. On April 8, 2024, and September 16, 2024, the preventive maintenance (PM) program documented the presence of scratches and cracks on the(b)(4)cover and(b)(4)in the equipment checklist. These issues were also observed during the July 2023 inspection. However, CAPAs were not implemented until after the current inspection, when the deficiency was again noted.Aseptic processes should be designed to minimize exposure of sterile articles to potential contamination hazards, including, but not limited to, an adequate cleaning, disinfection, and sterilization process of movable parts. A suitable facility monitoring system is critical to maintain appropriate environmental conditions throughout all your cleanrooms. All deviations from established limits should be appropriately investigated to rapidly detect atypical changes that can compromise the facility’s environment. Prompt detection of an emerging problem is essential to preventing contamination of your aseptic production operations. Additionally, your clean rooms should be designed as a functional unit and for a specific purpose. For example, an adequate design includes seamless and rounded floor-to-wall junctions, as well as readily accessible corners that are easy to clean.In your response, you state(b)(4)are used to clean and disinfect the filling line surfaces(b)(4), and that sporicidal decontamination using(b)(4)solution is performed(b)(4). You also indicated that you would conduct a study to evaluate the efficacy of(b)(4)against mold species. Additionally, you state that a bio-decontamination process of filling machine surfaces ISO 5 (Grade A) will be implemented using a sporicidal product within defined frequency. You also indicate that the(b)(4)aseptic filling(b)(4)doors were changed.Your response is inadequate. You did not provide a risk assessment to determine if the drug products manufactured by your facility for the U.S. market are not compromised for sterility. Additionally, we are concerned that your preventive maintenance program did not correct the improper equipment conditions (i.e., scratches and cracks on the(b)(4)) which were documented but not repaired.In response to this letter, provide the following:A CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning and disinfection processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment cleaning and disinfection. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning and disinfection execution for all products and equipment; and all other needed remediations.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.A comprehensive assessment of your facility, especially of those areas and rooms where mold species have been identified. This assessment should include a detailed remediation plan describing root causes for the presence of the mold species found and how you intend to reduce or eliminate potential sources to prevent recurrence.Drug Production CeasedWe acknowledge your commitment to cease production of the traditional(b)(4)fill lines(b)(4)at this facility. In response to this letter, clarify whether you intend to resume manufacturing drugs for the U.S. market at this facility in the future.If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPAs.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to any violations.Failure to address any violations may also result in the FDA refusing admission of articles manufactured at Excelvision, located at Rue de la Lombardiere, Annonay, Ardeche, France, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days1. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3007058211and ATTN: Rafael E. Arroyo.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research_________________1Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

案件名称葫芦岛市顺康医药连锁有限公司销售劣药“羌活”案处罚决定文书号辽药监(稽十四)罚〔2025〕2号被处罚企业名称葫芦岛市顺康医药连锁有限公司统一社会信用代码912114027915934461法定代表人孟凡鹏主要违法事实当事人销售劣药羌活，违法所得1091.70元。行政处罚种类和依据没收违法所得。依据《中华人民共和国药品管理法》第一百一十七条第一款及《中华人民共和国药品管理法实施条例》第七十五条。处罚结果没收违法所得1091.70元。行政处罚履行方式和期限主动履行；当事人已于2025年5月7日履行完毕。作出处罚的日期2025-04-30

为加强药品质量监管，保障公众用药安全，根据广东省药品抽检计划,广东省药品监督管理局组织对全省药品生产、经营、使用环节进行药品质量抽查检验，现将药品质量抽查检验结果予以通告（见附件）。附件：药品质量抽查检验结果（2025年第4期）广东省药品监督管理局2025年5月12日

2025年4月，浙江省内各市市场监督管理局共新备案第一类医疗器械产品178个，其中有源类6个，无源类73个，体外诊断试剂99个（具体产品见附件）。按照备案人所在辖区分析，杭州市60个，湖州市1个，嘉兴市4个，金华市15个，宁波市33个，绍兴市25个，台州市8个，温州市31个，衢州市1个。特此通告。2025年4月第一类医疗器械备案产品目录浙江省药品监督管理局2025年5月12日

行政相对人名称连云港时代医药连锁有限公司行政相对人类别法人及非法人组织统一社会信用代码91320722MA1T54UM4B工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人张磊法定代表人证件类型身份证法定代表人证件号码3****************1证件类型证件号码行政处罚决定书文号苏药监（连）药处字〔2025〕2号违法行为类型当事人销售假药四味脾胃舒颗粒的行为，违反了《中华人民共和国药品管理法》第九十八条第一款、第二款第（一）（二）项规定。违法事实当事人销售假药四味脾胃舒颗粒的行为，违反了《中华人民共和国药品管理法》第九十八条第一款、第二款第（一）（二）项规定。处罚依据依据《中华人民共和国药品管理法实施条例》第七十五条“药品经营企业、医疗机构未违反《中华人民共和国药品管理法》和本条例的有关规定，并有充分证据证明其不知道所销售或者使用的药品是假药、劣药的，应当没收其销售或者使用的假药、劣药和违法所得;但是，可以免除其他行政处罚”、《中华人民共和国行政处罚法》第二十八条“行政机关实施行政处罚时，应当责令当事人改正或者限期改正违法行为。当事人有违法所得，除依法应当退赔的外，应当予以没收”之规定，考虑当事人违法行为的事实、性质、情节、产品的风险性以及社会危害程度，鉴于当事人主动履行了《中华人民共和国药品管理法》及其“实施条例”索证索票等法定义务，且并不知情所销售的药品是假药，能在调查期间积极配合药监部门调查，如实陈述事实，及时提交相关材料，主动进行原因分析排查自查自纠情节。处罚类别没收违法所得处罚内容没收违法所得2179.46元罚款金额（万元）没收违法所得没收非法财物的金额（万元）0.22暂扣或吊销证照名称及编号处罚决定日期2025/05/12处罚有效期2025/11/12公示截止期2026/05/12处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注

行政相对人名称扬州市蕾丝特日化有限公司行政相对人类别法人及非法人组织统一社会信用代码91321016MA1N565N33工商注册号组织机构代码税务登记号事业单位证书号社会组织登记证号法定代表人田盛宏法定代表人证件类型身份证法定代表人证件号码3****************1证件类型证件号码行政处罚决定书文号苏药监扬处罚〔2025〕1号违法行为类型生产经营标签不符合规定的化妆品的行为，违反了《化妆品监督管理条例》第三十五条规定、第三十六条规定。违法事实扬州市蕾丝特日化有限公司，生产经营标签不符合规定的化妆品的行为，违反了《化妆品监督管理条例》第三十五条规定、第三十六条规定，依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十一条第一款第五项规定，应予处罚。处罚依据依据《中华人民共和国行政处罚法》第二十八条第一款、《化妆品监督管理条例》第六十一条第一款第五项规定。处罚类别罚款;没收违法所得、没收非法财物处罚内容没收违法所得叁佰叁拾元整；处以罚款壹万贰仟元整罚款金额（万元）1.2没收违法所得没收非法财物的金额（万元）0.033暂扣或吊销证照名称及编号处罚决定日期2025/05/12处罚有效期2025/11/12公示截止期2028/05/12处罚机关江苏省药品监督管理局处罚机关统一社会信用代码11320000014000394R数据来源单位江苏省药品监督管理局数据来源单位统一社会信用代码11320000014000394R备注公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。