2024年度药品审评报告.pdf相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称七台河市岚之峰大药房行政相对人代码(统一社会信用代码)91230900MA1CBMJ787法定代表人范井海行政处罚决定书文号七市监处罚〔2025〕2006号违法行为类型《中华人民共和国药品管理法》第五十五条规定违法事实违反了《中华人民共和国药品管理法》第五十五条规定处罚依据《中华人民共和国药品管理法》第一百二十九条处罚类别罚款;没收非法财物处罚内容罚款10万元，没收违法购进的药品罚款金额（万元）10处罚决定日期2025-03-18处罚有效期2028-03-18公示截止期2028-03-18处罚机关七台河市市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称黑龙江龙卫医药连锁有限公司成明河药店行政相对人代码(统一社会信用代码)91230128MA1AYTA65T法定代表人叶亚贤行政处罚决定书文号通河市监处罚〔2025〕37号违法行为类型未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度的行为违法事实当事人未建立化妆品进货验质台账处罚依据《化妆品监督管理条例》 / 第六十二条 / 第一款 / 第二项有下列情形之一的，由负责药品监督管理的部门责令改正，给予警告，并处1万元以上3万元以下罚款；情节严重的，责令停产停业，并处3万元以上5万元以下罚款，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处1万元以上3万元以下罚款：（二）未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度；;《化妆品生产经营监督管理办法》 / 第六十二条 / 第一款化妆品生产经营者违反法律、法规、规章、强制性国家标准、技术规范，属于初次违法且危害后果轻微并及时改正的，可以不予行政处罚。处罚类别警告;罚款处罚内容1.警告；2.罚款人民币3000元整。罚款金额（万元）0.3处罚决定日期2025-03-18处罚有效期2099-12-31公示截止期2025-06-18处罚机关通河县市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称通河县百姓大药房有限公司行政相对人代码(统一社会信用代码)91230128MA18WK5T4Q法定代表人郭晓光行政处罚决定书文号通河市监处罚〔2025〕38号违法行为类型未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度的行为违法事实当事人未建立化妆品进货验质台账处罚依据《化妆品监督管理条例》 / 第六十二条 / 第一款 / 第二项有下列情形之一的，由负责药品监督管理的部门责令改正，给予警告，并处1万元以上3万元以下罚款；情节严重的，责令停产停业，并处3万元以上5万元以下罚款，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处1万元以上3万元以下罚款：（二）未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度；;《化妆品生产经营监督管理办法》 / 第六十二条 / 第一款化妆品生产经营者违反法律、法规、规章、强制性国家标准、技术规范，属于初次违法且危害后果轻微并及时改正的，可以不予行政处罚。处罚类别警告;罚款处罚内容1.警告；2.罚款人民币3000元整罚款金额（万元）0.3处罚决定日期2025-03-18处罚有效期2099-12-31公示截止期2025-06-18处罚机关通河县市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

行政相对人名称哈尔滨人民同泰医药连锁有限公司通河分店行政相对人代码(统一社会信用代码)91230128MA1C47P42U法定代表人贾建军行政处罚决定书文号通河市监处罚〔2025〕44号违法行为类型未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度的行为违法事实当事人未建立化妆品进货验质台账处罚依据《化妆品监督管理条例》 / 第六十二条 / 第一款 / 第二项有下列情形之一的，由负责药品监督管理的部门责令改正，给予警告，并处1万元以上3万元以下罚款；情节严重的，责令停产停业，并处3万元以上5万元以下罚款，对违法单位的法定代表人或者主要负责人、直接负责的主管人员和其他直接责任人员处1万元以上3万元以下罚款：（二）未依照本条例规定建立并执行进货查验记录制度、产品销售记录制度；;《化妆品生产经营监督管理办法》 / 第六十二条 / 第一款化妆品生产经营者违反法律、法规、规章、强制性国家标准、技术规范，属于初次违法且危害后果轻微并及时改正的，可以不予行政处罚。处罚类别警告;罚款处罚内容1.警告；2.罚款人民币3000元整。罚款金额（万元）0.3处罚决定日期2025-03-18处罚有效期2099-12-31公示截止期2025-06-18处罚机关通河县市场监督管理局相关推荐CIO提供以下相关文库下载、合规服务以及线上培训课程学习。

Delivery Method:VIA EMAIL AND UNITED PARCEL SERVICEReference #:25-HFD-45-03-01Product:DrugsRecipient:Mehran Michael Bahrami, M.D.2390 NE 186th StreetAventura,FL33180United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERFDA Ref. No.: 25-HFD-45-03-01Dear Dr. Bahrami:This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at your clinical site between April 8 and April 19, 2024. Investigators Chantae D. Mitchell and Ana P. Barido, representing FDA, reviewed your conduct of the following clinical investigations:Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).Protocol(b)(4), “(b)(4),” of the investigational drug(b)(4), performed for(b)(4).This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected.At the conclusion of the inspection, Investigators Mitchell and Barido presented and discussed with you the Form FDA 483, Inspectional Observations. We acknowledge receipt of your April 30, 2024, written response to the Form FDA 483.From our review of the FDA Establishment Inspection Report, the documents submitted with that report, and your written response dated April 30, 2024, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, part 312 (21 CFR 312), governing the conduct of clinical investigations and the protection of human subjects. We wish to emphasize the following:1. You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plans for Protocols(b)(4)and(b)(4)required you to ensure that subjects met all eligibility criteria before enrollment in the studies. In addition, the investigational plan for Protocol(b)(4)required you to conduct certain study visits and procedures in-person, which included certain safety laboratory assessments at specific study visits. You failed to adhere to these requirements.Examples of this failure include, but are not limited to, the following:a. The investigational plan for Protocol(b)(4)required subjects to meet all inclusion criteria to be eligible for study participation, including, but not limited to, (1)(b)(4)symptom onset less than or equal to 7 days before randomization, and (2)(b)(4)infection first confirmed by PCR, nucleic acid testing, or direct antigen testing, with samples collected less than or equal to 4 days before randomization. You failed to adhere to this requirement.Specifically, Subject(b)(6)was documented as having symptoms of possible(b)(4)on January 26, 2021, approximately 15 days before the subject was randomized on February 10, 2021. This is more than the protocol-required time frame for(b)(4)symptom onset of within 7 days before randomization. In addition, the subject’s samples confirming(b)(4)infection were collected on January 27, 2021, approximately 14 days before randomization. This is more than the protocol-required time frame for sample collection of within 4 days before randomization.In your April 30, 2024, written response, you stated that subjects who did not meet the inclusion criteria were excluded from the study. However, study records demonstrate that Subject(b)(6)was enrolled and administered study drug between February 10 and 14, 2021.b. The investigational plan for Protocol(b)(4)required you to exclude subjects from the study if they had one or more conditions associated with a high risk for severe(b)(4), including, but not limited to, smoking (current and former). You failed to adhere to this requirement.Specifically, Subjects(b)(6)and(b)(6)were documented as being current smokers and as having a history of smoking. However, Subjects(b)(6)and(b)(6)were enrolled and randomized on December 3, 2022, and December 19, 2022, respectively.In your April 30, 2024, written response, you stated that risk factors for smoking were re-evaluated, and that subjects were excluded from the study who did not meet inclusion criteria. However, study records demonstrate that Subjects(b)(6)and(b)(6)were enrolled and administered study drug between December 3 and 7, 2022, and between December 19 and 23, 2022, respectively.c. The investigational plan for Protocol(b)(4)required study visits for Day 1 through Day 20 to be conducted in-person. The protocol defined an in-person visit as a visit conducted at a medical facility or elsewhere by a health care provider (where permitted). Additionally, study procedures including vital signs, physical examination, and safety laboratory assessments were to be conducted during specific protocol-required in-person study visits, in accordance with the schedule of study procedures. You failed to adhere to these requirements.Specifically, Subjects(b)(6), and(b)(6)had virtual visits for Day 3 (May 19, 2023), Day 5 (May 21, 2023), Day 10 (May 26, 2023), and Day 15 (May 31, 2023), instead of in-person visits, as required by the protocol. As a result, in-person study procedures including vital signs, physical examination, and safety laboratory assessments were not performed in accordance with the schedule of study procedures.In your April 30, 2024, written response, you stated that the four subjects who were administered investigational product had all in-person visits except three subjects who had virtual visits, who were excluded from the study. However, study records demonstrate that these four subjects were enrolled and administered study drug between May 17 and May 21, 2023.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan. Your failure to ensure that subjects met the protocol-required eligibility criteria before enrollment in the study, and your failure to perform study visits and safety laboratory assessments in accordance with the protocol, raise significant concerns about your protection of the study subjects enrolled at your site, and raise concerns about the validity and integrity of the data collected at your site.2. You failed to retain records required to be maintained under 21 CFR 312 for a period of two years following the date a marketing application is approved for the drug for the indication for which the drug is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until two years after the investigation is discontinued [21 CFR 312.62(c)].As a clinical investigator, you are required to retain adequate and accurate case histories that record all observations and other data pertinent to the investigation for each individual administered the investigational drug or employed as a control in the investigation. You are required to retain these records for a period of two years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or the application is not approved for such indication, until two years after the investigation is discontinued and FDA is notified. You failed to adhere to these requirements.Specifically, for Protocols(b)(4)and(b)(4), you failed to retain electronic case report forms for all randomized subjects. You were required to retain case histories, including electronic case report forms, until two years after the investigation was discontinued and FDA was notified, which was on May 2, 2024; however, these records were not available for review during the inspection conducted at your clinical site.In your April 30, 2024, written response, you stated that you were hired as an employee for the site as a Principal Investigator and that all the studies were appropriately and professionally completed until Protocol(b)(4), when the site owner no longer observed employee’s work, discussed performance with you, and was not present at the site for extended periods. Further, you stated that the case report form was requested from the site owner, but she did not reply to your requests, and you terminated your contract with the site. However, as the clinical investigator, it is your responsibility to retain the study records for both protocols because it has not yet been two years since either investigation was discontinued. Your failure to retain study records as required by FDA regulations raises concerns about the validity and integrity of the data collected at your site.While we acknowledge the information provided in your written response, your written response is inadequate because you did not provide information about any completed or proposed corrective actions, or about how you, as the clinical investigator, would prevent similar violations in the future. For example, you did not provide sufficient details about any policies and procedures you would institute at your site to ensure compliance with study protocols when conducting future clinical investigations. Additionally, you did not provide details concerning any planned or completed training on the responsible conduct of clinical trials or compliance with FDA regulations. Without this information, we are unable to determine whether your corrective actions appear adequate to prevent similar violations in future clinical investigations.We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted properly and in compliance with FDA regulations, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data. Your failure to conduct the clinical study in accordance with the protocol and your failure to retain study records raise significant concerns about your protection of the study subjects enrolled at your site, and raise concerns about the validity and integrity of the data collected at your site.This letter is not intended to be an all-inclusive list of deficiencies with your clinical study of an investigational drug. It is your responsibility to ensure adherence to each requirement of the law and relevant FDA regulations. You should address any deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.This letter notifies you of our findings and provides you with an opportunity to address the deficiencies noted above. Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future. Failure to address this matter adequately may lead to regulatory action. If you believe you have complied with the FD&C Act and relevant regulations, please include your reasoning and any supporting information for our consideration.If you have any questions, you may email FDA at CDER-OSI-Communications@fda.hhs.gov.Your written response and any pertinent documentation should be addressed to:Brittany L. Garr-Colón, MPHBranch ChiefCompliance Enforcement BranchDivision of Enforcement and Postmarketing SafetyOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug AdministrationBuilding 51, Room 535210903 New Hampshire AvenueSilver Spring, MD 20993Sincerely yours,{See appended electronic signature page}David C. Burrow, Pharm.D., J.D.DirectorOffice of Scientific InvestigationsOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed electronically. Following this are manifestations of any and all electronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------DAVID C BURROW03/05/2025 07:44:08 AM

Delivery Method:Via EmailReference #:320-24-46Product:DrugsRecipient:Suvil ParikhVice President of OperationsVegewax Candleworx Ltd.300 North Rivermede Rd.ConcordONL4K 3N6CanadaSuvil@scentsalive.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-24-46June 14, 2024Dear Mr. Parikh:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Vegewax Candleworx Ltd., FEI 3005787511, at 300 North Rivermede Rd., Concord, from October 16 to 19, 2023.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 2, 2023 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.During our inspection, our investigator 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 (21 CFR 211.84(d)(1) and 211.84(d)(2)).You failed to perform adequate identity testing for each component lot used in the production of your over-the-counter (OTC) drug products, including(b)(4), your active pharmaceutical ingredient (API). Additionally, you did not test(b)(4)content and(b)(4)for the presence of(b)(4). You relied on the certificates of analysis (COAs) from your suppliers and failed to establish the reliability of each of your suppliers’ COA for component specifications and characteristics.Component testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your incoming components conform to appropriate specifications before use in the manufacture of drug products.Products Contain(b)(4)You manufacture multiple drugs that contain(b)(4). The use of(b)(4)contaminated with(b)(4)has resulted in various lethal poisoning incidents in humans worldwide.See FDA’s guidance document(b)(4).(b)(4)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)Your response is inadequate. You fail to address the full scope and impact of the CGMP deficiencies as well as the associated risks to drug product quality, including addressing batches already in distribution. With respect to your(b)(4)containing products, you have not addressed if your evaluation will include all lots of(b)(4)for each drug product batch you manufactured and that remains within shelf-life in the U.S. market. Without appropriate testing of components and ingredients, you cannot ensure the quality and safety of your drug products.In response to this letter, provide:A commitment to provide(b)(4)test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of(b)(4).A full risk assessment for drug products that are within expiry which contain any ingredient at risk for(b)(4)contamination (including, but not limited to,(b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain(b)(4), including customer notifications and product recalls for any contaminated lots. Identify additional appropriate corrective actions and preventive actions (CAPA) that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.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 glycerin, propylene glycol, 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.The chemical quality control specifications you use to test each incoming lot of high-risk drug components to determine acceptability for use in manufacturing.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.A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.2. Your firm’s quality control unit failed to review and approve all drug product production and control records to determine compliance with all established, approved written procedures before a batch is released or distributed (21 CFR 211.192).Out-of-specification (OOS) assay resultsIn November 2020, your quality unit released for distribution a(b)(4)batch that failed potency testing. Instead of conducting a thorough investigation, you(b)(4)the batch by adding more(b)(4)and released it under a new batch number in(b)(4). You failed to determine the root cause of the out-of-specification (OOS) and implement the appropriate CAPA.Microbiological resultsYou failed to adequately investigate multiple microbiological excursions in samples collected from your(b)(4)system in(b)(4). You also failed to isolate and speciate microorganisms, and to determine the root cause for out-of-limit (OOL) test results. In response to these excursions, you proposed CAPAs. However, your CAPAs were inadequate to prevent recurrence.In addition, you failed to identify batches potentially contaminated with(b)(4), produced at your facility between the referenced sampling periods.In your response, you state that your(b)(4)batch is expired. However, your response is inadequate because your investigations are limited in scope and lack comprehensive review for potentially affected products and root cause determination. Additionally, you failed to provide any supporting documentation, including details of your corrective actions, with your initial 483 response.In response to this letter, provide:A retrospective, independent review of all OOS (including in-process and release/stability testing) results for U.S. products currently in the U.S. market and within expiry as of the date of this letter and a report summarizing the findings of the analysis, including the following for each OOS:o Determine whether the scientific justification and evidence relating to the OOS result conclusively or inconclusively demonstrates causative laboratory error.o For investigations that conclusively establish laboratory root cause, provide rationale and ensure that all other laboratory methods vulnerable to the same or similar root cause are identified for remediation.o For all OOS results found by the retrospective review to have an inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, suitability of equipment/facilities, variability of raw materials, process capability, deviation history, complaint history, batch failure history). Provide a summary of potential manufacturing root causes for each investigation, and any manufacturing operation improvements.A comprehensive review and remediation plan for your OOS result investigation systems. The CAPA should include but not be limited to addressing the following:o Quality unit oversight of laboratory investigationso Identification of adverse laboratory control trendso Resolution of causes of laboratory variationo Initiation of thorough investigations of potential manufacturing causes whenever a laboratory cause cannot be conclusively identifiedo Adequately scoping of each investigation and its CAPAo Revised OOS investigation procedures with these and other remediationsA summary of the steps you have taken to ensure timely root cause evaluations and effective CAPA for all drug products.A report of periodic assessments of the implementation and effectiveness of CAPAs.A commitment to increase the frequency of your microbial testing to an appropriate time frame (e.g., at least daily).A detailed risk assessment addressing potential effects of water system deficiencies on the quality of all aqueous-based drug product lots currently on the market within expiry.We acknowledge your commitment to use purchased purified water for production of drug products and cleaning your production equipment. Provide your plan for qualification of your purified water supplier, an analysis on the water prior to release of the water for use, and control of the water during the production and cleaning process.Quality SystemsYour firm’s quality systems are inadequate. 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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.Test Results Out-of-SpecificationFor more information about handling failing, out-of-specification, out-of-trend, or other unexpected results and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Productionat https://www.fda.gov/media/158416/downloadCGMP 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 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 audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violation 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.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 Vegewax Candleworx, Ltd., 300 North Rivermede Rd., Concord, Ontario, L4K 3N6, Canada, 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 3005787511 and ATTN: Yasamin Ameri.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Product:Drugs\Over-the-Counter DrugsRecipient:Eric Kreider, M.S.Kabana Skin Care685 S Arthur Ave Unit 9BLouisville,CO80027United StatesErik@kabanaskincare.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 12, 2025RE: 688254Dear Mr. Kreider:This letter is to advise you that in June 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including at the internet address https://kabanaskincare.com/ where your “Kabana Body Wash +UV” product is available for purchase in the United States without a prescription.Your “Kabana Body Wash +UV” product is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food Drug & Cosmetic Act (FD&C Act), 21 U.S.C. 355(a), and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). Introduction or delivery for introduction of such products into interstate commerce is prohibited under sections 301(d) and (a) of the FD&C Act, 21 U.S.C. 331(d) and (a). These violations are described in more detail below.Unapproved New Drug and Misbranding ViolationsYour “Kabana Body Wash +UV” product is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is 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 it is intended to affect the structure or any function of the body.Examples of the claims from the product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:“How does Zinc Oxide work in terms of UV protection?...Zinc Oxide is an excellent sunscreen because it has the broadest UV protective spectrum and cannot be absorbed into your blood… effectively providing a layer of armor against damaging UV rays …“Try our zinc oxide Sunscreens!” [from the FAQ page on your website https://kabanaskincare.com/frequently-asked-questions/ that links to your sunscreen product page which directs consumers to purchase Kabana Body Wash + UV under the hyperlinked word “Sunscreens” https://kabanaskincare.com/product-cat/sunscreens/ ]“Sunscreens… Kabana Body Wash +UV” [from the sunscreen product page on your website which directs consumers to purchase Kabana Body Wash + UV https://kabanaskincare.com/product-cat/sunscreens/ ]“Customers Say…I have a tendency to not use any kind of UV protection at all…I've used the body wash particularly… on my head for about 2 weeks and have noticed a definite increase in UV protection when I'm under the sun…My head has not been burned once this year.” [from the Customers Say section at the bottom of the Kabana Body Wash +UV product page https://kabanaskincare.com/products/kabana-body-wash-uv/ ]“Body Wash UV…I’ve been using Body Wash UV every day in the shower for about three weeks…I had about 3 hours of direct sun exposure, which was definitely in burn area … I couldn’t believe it. I was like – how did I not get burned? Then it hit me – Body Wash UV! I use it everyday…The fact that it protects me from getting roasted when I don’t put sun block lotion on is awesome. [from the Testimonial page on your website https://kabanaskincare.com/kabana-organic-skin-care-testimonials/#4]Based on the above labeling claims, your “Kabana Body Wash +UV” drug product is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product. Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your product. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if, among other things, they conform to the conditions of use set forth in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC 000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a body wash dosage form. As previously stated, there is no FDA-approved application in effect for your drug product.Thus, even if your product were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “Kabana Body Wash +UV” sunscreen drug product is a misbranded drug introduced or delivered for introduction into interstate commerce in violation of sections 502(ee) and 301(a) of the FD&C Act, 21 U.S.C. 352(ee) and 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration_________________________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6024 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6024 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act.

Delivery Method:VIA UPSReference #:320-25-52Product:DrugsRecipient:Mr. Robert C. MundayQuality and Regulatory AdvisorInternational Laboratories CorpBangplee District, 62 Moo 8,Bang Na-Trat RdBang PhliSamut Prakan10540ThailandIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter320-25-52March 10, 2025Dear Mr. Munday:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, International Laboratories Corp, FEI 3006403166, at Bangplee District, 62 Moo 8, Bang Na-Trat Rd, Bang Phli, Samut Prakan 10540, Thailand, from September 16 to 20, 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 October 11, 2024 response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)).Your laboratory records lacked complete and reliable original data to support the chromatographic analyses performed on over-the-counter (OTC) drug products and components. For example, our investigators documented multiple examples of fabricated laboratory records. During the inspection, your Laboratory Manager stated that your firm fabricated several laboratory investigations that were not performed. A senior Quality Assurance Manger also confirmed that laboratory investigations were fabricated in preparation for the FDA inspection. Further, you did not maintain the original data from the analytical testing of raw materials and finished products.In your response, you acknowledge that your laboratory system lacks appropriate procedures and controls to ensure the completeness and integrity of your data and you committed to improvements. Your response is inadequate as it does not adequately evaluate the full scope of data integrity (DI) deficiencies throughout your drug product manufacturing operations.Reliability of data is fundamentally compromised when there is a failure to record or maintain complete and accurate records of test results, or conditions associated with all tests. Furthermore, the lack of reliable data compromises the quality unit’s (QU) ability to exercise its function of ensuring compliance to applicable standards.2. Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).Your laboratory equipment, used to generate analytical data for finished drug product release and stability testing, lacked restricted access and sufficient controls. Specifically, your firm did not have proper controls in place to prevent the deletion or record manipulation of your laboratory's electronic raw data. For example, our investigator documented numerous examples of deleted electronic raw data files. Additionally, your analysts had administrative rights capable of altering and deleting data, files, and folders on your chromatographic systems, including the date and time of tests.We also note that you did not ensure retention of complete electronic raw data for all laboratory instrumentation and equipment. For example, our investigators documented several electronic data results that were not available for review.In your response, you acknowledge the lack of document control and state that you have initiated change controls to reduce DI gaps identified during the inspection. Your response is inadequate because you failed to include a comprehensive review of each piece of equipment and the impact of the significant adverse pattern of data that has been discarded or lost. Your impact assessment commitment is also limited to missing(b)(4)test data and stability.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 WithDrug CGMPfor guidance on establishing and following CGMP compliant DI practices at https://www.fda.gov/media/119267/download.We strongly recommend that you retain an independent third-party qualified consultant to assist in your remediation. In response to this letter, provide:A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Your investigation should include:o A detailed investigation protocol and methodology; a summary of all laboratories, manufacturing operations, and systems to be covered by the assessment; and a justification for any part of your operation that you propose to exclude.o Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies. We recommend that these interviews be conducted by a qualified third party.o An assessment of the extent of DI deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered DI lapses. o A comprehensive retrospective evaluation of the nature of the testing/manufacturing/other DI deficiencies. We recommend that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all DI 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 DI and analyses of the risks posed by ongoing operations.A management strategy for your firm that includes the details of your global corrective action and preventive action (CAPA) plan. Your strategy should include:o A detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate, including analytical data, manufacturing records, and all data submitted to FDA.o A comprehensive description of the root causes of your DI lapses, including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for DI lapses remain able to influence CGMP-related or drug application data at your firm.o Interim measures describing the actions you have taken or will take to protect patients and to ensure the quality of your drugs, such as notifying your customers, recalling product, conducting additional testing, adding lots to your stability programs to assure stability, drug application actions, and enhanced complaint monitoring.o Long-term measures describing any remediation efforts and enhancements to procedures, processes, methods, controls, systems, management oversight, and human resources (e.g., training, staffing improvements) designed to ensure the integrity of your company’s data.o A commitment to have a qualified consultant conduct extensive annual audits, for at least 2 years, to assist in evaluating CAPA effectiveness after you have executed your DI remediation protocol.o Inform FDA if you will be hiring a Chief Integrity Officer who is fully empowered to receive anonymous complaints from employees reporting DI concerns and with the authority to ensure any potential breach is promptly investigated (by independent quality assurance function, along with expertise from outside entities whenever needed).o A status report for any of the above activities already underway or completed.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)).Your QU did not provide adequate oversight for the manufacture of your products. For example, you stated that you could not provide records to support the CGMP requirements for the manufacture of drugs, including but not limited to the following:Finished product original release testing dataOriginal stability testing dataSample collection and preparationProcedures for quality control data review (e.g., raw material, finished product release, and stability testing)Batch production and control recordIn your response, you state that controls are being implemented to establish requirements for CGMP activities across operations and laboratory staff. Your response is inadequate. You failed to address the potential impacts on all drug product lots distributed to the United States that remain within expiry and were manufactured without documentation of testing performed.In a previous warning letter (320-23-34), FDA cited similar CGMP violations. You proposed remediation and committed to conducting a full six-system audit with a qualified CGMP consultant in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.In your 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.o Also describe how top management supports quality assurance and reliable operations, including but not limited to, timely provision of resources to proactively address emerging manufacturing/quality issues and to assure a continuing state of control.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 August 7, 2023, after your response to our 704(a)(4) Request for Records sent to you on March 17, 2023, demonstrated CGMP violations related to controls for DEG/EG in high-risk components used in your drugs.The inspectional findings detailed above further demonstrate your firm’s noncompliance.Your firm remains on Import Alert 66-40.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 International Laboratories Corp, Bang Phli, Samut Prakan 10540, Thailand, 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 3006403166 and ATTN: Zachary Bogorad.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research

Product:Drugs\Over-the-Counter DrugsRecipient:Laura E. Cohen, M.D.PresidentCoLabs Intl. Corp7251 W. Lake Mead Blvd Ste. 300Las Vegas,NV89128United Statesinfo@klenskin.comInfo@colabsintl.comIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWARNING LETTERMarch 12, 2025RE: 688285Dear Dr. Cohen:This letter is to advise you that in May 2024, the U.S. Food and Drug Administration (FDA) reviewed your product labeling, including on your website at the internet address https://www.klenskin.com/ where your “KLĒNSKIN WASH ON SUNSCREEN” drug product is available for purchase without a prescription.Your “KLĒNSKIN WASH ON SUNSCREEN” product is a “drug” as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because it is 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 it is intended to affect the structure or any function of the body.Examples of the claims from the product labeling, including your website listed above, that provide evidence of the intended uses (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:“The first — and only — clinically proven Wash On® sunscreen. Our fragrance-free formula doesn’t just leave your skin and scalp moisturized; it also provides broad-spectrum SPF 30 protection…” [from your “KLĒNSKIN WASH ON SUNSCREEN” product website]“WHY YOU’LL LOVE OUR FRANGRANCE FREE WASH ON…UVA/UVB broad-spectrum SPF 30…” [from your “KLĒNSKIN WASH ON SUNSCREEN” product website]“Wash On® Sunscreen is as easy as washing your face. (But with broad-spectrum SPF 30 protection) …Our gentle creamy cleanser provides a powerful protective layer making it perfect everyday sunscreen for sensitive skin.” [from your “KLĒNSKIN WASH ON SUNSCREEN” product website]Based on the above labeling, your “KLĒNSKIN WASH ON SUNSCREEN” is intended for use as an over-the-counter (OTC) sunscreen drug product. No FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for your drug product.Section 505G of the FD&C Act, 21 U.S.C. 355h, governs the marketing of nonprescription drugs that are marketed without an approved application under section 505 of the FD&C Act, 21 U.S.C. 355, such as your product. Under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), a nonprescription drug is misbranded if the drug is subject to section 505G of the FD&C Act, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355.Section 505G of the FD&C Act, 21 U.S.C. 355h, provides that certain nonprescription drugs are deemed to be generally recognized as safe and effective (GRASE) and not new drugs if they, among other things, conform to the conditions in the applicable OTC monograph. In the case of OTC sunscreen drug products, the applicable OTC monograph is set forth in the final administrative order, OTC000006: Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use (hereinafter M020), which was deemed a final order by 505G(b)(8) and 505G(k)(2)(B).1However, under section 505G(m)(2), “notwithstanding subsection [505G](a),” sunscreens in dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder may only be lawfully marketed, without an application approved under section 505 of the FD&C Act, pursuant to an order issued under section 505G of the FD&C Act.2To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of a shampoo or face/body wash dosage form for sunscreen. As previously stated, there is no FDA-approved application in effect for your drug product.Thus, even if your product were in conformity with the conditions set forth in M020 and all other applicable requirements to be deemed GRASE and not a new drug under section 505G(a)(1), it does not comply with the requirements under section 505G. Accordingly, your “KLĒNSKIN WASH ON SUNSCREEN” drug product is a misbranded drug introduced or delivered for introduction into interstate commerce in violation of sections 502(ee) and 301(a) of the FD&C Act, 21 U.S.C. 352(ee) and 331(a).ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the correction. Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance by email to FDAAdvisory@fda.hhs.gov and include your firm name in the subject line of your email.Sincerely,/S/Tina Smith, M.S.Captain, U.S. Public Health ServiceDirectorOffice of Unapproved Drugs & Labeling ComplianceOffice of ComplianceCenter for Drug Evaluation and ResearchU.S. Food and Drug Administration___________________________1See sections 505G(a)(1) and (2) of the FD&C Act and see Order ID OTC000006, available at FDA’s website OTC Monographs@FDA, https://dps.fda.gov/omuf. As required by section 505G(a)(2), M020 encompasses the requirements specified in part 352 of title 21, Code of Federal Regulations, as published on May 21, 1999, beginning on page 27687 of volume 64 of the Federal Register, except that the applicable requirements governing effectiveness and labeling shall be those specified in section 201.327 of title 21, Code of Federal Regulations.2Section 505G(m)(2) provides that “[n]otwithstanding subsection [505G](a),” a drug that, “prior to the date of the enactment of this section [March 27, 2020], the Secretary determined in a proposed or final rule to be ineligible for review under the OTC drug review” (emphasis added) may not be legally marketed without an approved NDA or ANDA except as “pursuant to an order issued under this section”. In a 2019 proposed rule, FDA determined that sunscreens in all dosage forms other than oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder were ineligible for review under the OTC Drug Review under the then-operative requirements because we did not receive data showing that they were marketed prior to 1972. 84 FR 6024 at 6229-6230 (Feb. 26, 2019); see also 84 FR 6024 at 6206 and 6272. Therefore, under section 505G(m)(2) of the FD&C Act, a sunscreen in any dosage form other than the ten dosage forms listed above may only be marketed with an approved application, unless FDA determines otherwise in an order issued under section 505G of the FD&C Act. To date, no final order has been issued by the Secretary under 505G(b) or 505G(c) that would authorize marketing of sunscreen in a shampoo or face/body wash dosage form.