[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-global-cosmetics-company-limited-677948-04302024":3,"fda-latest-sync-dates":29},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},1476,"global-cosmetics-company-limited-677948-04302024","Warning Letter","Global Cosmetics Company Limited",null,"Center for Drug Evaluation and Research | CDER","CGMP\u002FFinished Pharmaceuticals\u002FAdulterated","2024-05-07","2024-04-30","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fglobal-cosmetics-company-limited-677948-04302024","677948","Drugs","VIA UPS","Ms. Ranki Liu","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA UPS\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Ms. Ranki Liu\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Product Technical Manager\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Global Cosmetics Company Limited\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">No. 13 Gaobao Road, Changping Town\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Dongguan Shi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"administrative-area\">Guangdong Sheng\u003C\u002Fspan>, \u003Cspan class=\"postal-code\">523581\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">China\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research | CDER\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>Warning Letter\u003C\u002Fstrong> 320-24-35\u003C\u002Fp>\n\n\u003Cp>April 30, 2024\u003C\u002Fp>\n\n\u003Cp>Dear Ms. Liu:\u003C\u002Fp>\n\n\u003Cp>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 September 12, 2022 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Global Cosmetics (China) Company Limited, FEI 3013749236, at No. 13 Gaobao Road, Changping Town, Dongguan, Guangdong 523581, China.\u003C\u002Fp>\n\n\u003Cp>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).\u003C\u002Fp>\n\n\u003Cp>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 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).\u003C\u002Fp>\n\n\u003Cp>Following 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:\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1).\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>You manufactured OTC drug products including hand sanitizer.\u003Csup>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem>\u003C\u002Fsup> Based on the records and information you provided, you did not demonstrate that you are adequately testing the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate that you are adequately testing your active ingredient ethanol for methanol.\u003C\u002Fp>\n\n\u003Cp>Without adequate testing you do not have scientific evidence that your raw materials 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 assure adequate quality, including testing for the presence of methanol in ethanol.\u003C\u002Fp>\n\n\u003Cp>The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, \u003Cem>Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol\u003C\u002Fem>, at: https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F173005\u002Fdownload.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>2. 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)).\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>The records and information you provided did not demonstrate that your firm has an adequate stability program for the OTC hand sanitizer drug products that you manufacture. For example, your firm provided a stability test report which only included 12 weeks of stability data for a batch of hand sanitizer. In addition, you did not provide data demonstrating that adequate chemical and microbiological testing is performed on your drug products during stability testing.\u003C\u002Fp>\n\n\u003Cp>Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>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)).\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>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. 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.\u003C\u002Fp>\n\n\u003Cp>See FDA’s guidance document \u003Cem>Quality Systems Approach to Pharmaceutical CGMP Regulations\u003C\u002Fem> for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>CGMP Consultant Recommended\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>If your firm intends to resume manufacturing drugs for the U.S. market, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements before resuming drug manufacturing operations. 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 all corrective action and preventive action (CAPA) before you pursue resolution of your firm’s compliance status per FDA’s guidance document \u003Cem>Quality Systems Approach to Pharmaceutical CGMP Regulations\u003C\u002Fem>.\u003C\u002Fp>\n\n\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\n\n\u003Cp>The 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.\u003C\u002Fp>\n\n\u003Cp>FDA placed your firm on Import Alert 66-40 on February 16, 2024.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Global Cosmetics (China) Company Limited, No. 13 Gaobao Road, Changping Town, Dongguan, Guangdong 523581, 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 may be detained or refused admission.\u003C\u002Fp>\n\n\u003Cp>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.\u003C\u002Fp>\n\n\u003Cp>Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3013749236 and ATTN: Joel Hustedt.\u003C\u002Fp>\n\n\u003Cp>Sincerely,\u003Cbr>\n\u002FS\u002F\u003C\u002Fp>\n\n\u003Cp>Francis Godwin\u003Cbr>\nDirector\u003Cbr>\nOffice of Manufacturing Quality\u003Cbr>\nOffice of Compliance\u003Cbr>\nCenter for Drug Evaluation and Research\u003Cbr>\n\u003Cbr>\nCC:\u003C\u002Fp>\n\n\u003Cp>Registered US Agent\u003Cbr>\nLiberty Management Group Ltd.\u003Cbr>\n75 Executive Drive, Suite 114\u003Cbr>\nAurora, IL 60504\u003Cbr>\nmanoj@libertymanagement.us\u003C\u002Fp>\n\n\u003Cp>_____________________\u003C\u002Fp>\n\n\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, the FDA published the Guidance for Industry: \u003Cem>Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19)\u003C\u002Fem> on March 19, 2020, and subsequently updated the guidance several times. This guidance communicated the Agency’s temporary policy that we did not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepared alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance were present. These circumstances included preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). Because Global Cosmetics (China) Company Limited’s hand sanitizer products were not prepared under the circumstances described in this guidance, they do not fall within any temporary agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 501(a)(2)(B) of the FD&C Act.\u003C\u002Fp>\n\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA UPS\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMs. Ranki Liu\n\nRecipient Title\n\nProduct Technical Manager\n\nGlobal Cosmetics Company Limited\n\nNo. 13 Gaobao Road, Changping Town\n\nDongguan Shi\n\nGuangdong Sheng, 523581\n\nChina\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research | CDER\n\nUnited States\n\nWarning Letter 320-24-35\n\nApril 30, 2024\n\nDear Ms. Liu:\n\nYour 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 September 12, 2022 request for records and other information pursuant to section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for your facility, Global Cosmetics (China) Company Limited, FEI 3013749236, at No. 13 Gaobao Road, Changping Town, Dongguan, Guangdong 523581, China.\n\nThis 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).\n\nBecause 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 Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(B)).\n\nFollowing 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:\n\n1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1).\n\nYou manufactured OTC drug products including hand sanitizer.1 Based on the records and information you provided, you did not demonstrate that you are adequately testing the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate that you are adequately testing your active ingredient ethanol for methanol.\n\nWithout adequate testing you do not have scientific evidence that your raw materials 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 assure adequate quality, including testing for the presence of methanol in ethanol.\n\nThe use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, at: https:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F173005\u002Fdownload.\n\n2. 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)).\n\nThe records and information you provided did not demonstrate that your firm has an adequate stability program for the OTC hand sanitizer drug products that you manufacture. For example, your firm provided a stability test report which only included 12 weeks of stability data for a batch of hand sanitizer. In addition, you did not provide data demonstrating that adequate chemical and microbiological testing is performed on your drug products during stability testing.\n\nWithout appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.\n\n3. 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)).\n\nThe 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. 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.\n\nSee 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:\u002F\u002Fwww.fda.gov\u002Fmedia\u002F71023\u002Fdownload.\n\nCGMP Consultant Recommended\n\nIf your firm intends to resume manufacturing drugs for the U.S. market, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements before resuming drug manufacturing operations. 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 all corrective action and preventive action (CAPA) before you pursue resolution of your firm’s compliance status per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.\n\nConclusion\n\nThe 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.\n\nFDA placed your firm on Import Alert 66-40 on February 16, 2024.\n\nCorrect 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.\n\nFailure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Global Cosmetics (China) Company Limited, No. 13 Gaobao Road, Changping Town, Dongguan, Guangdong 523581, 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 may be detained or refused admission.\n\nThis 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.\n\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3013749236 and ATTN: Joel Hustedt.\n\nSincerely,\n\n\u002FS\u002F\n\nFrancis Godwin\n\nDirector\n\nOffice of Manufacturing Quality\n\nOffice of Compliance\n\nCenter for Drug Evaluation and Research\n\nCC:\n\nRegistered US Agent\n\nLiberty Management Group Ltd.\n\n75 Executive Drive, Suite 114\n\nAurora, IL 60504\n\nmanoj@libertymanagement.us\n\n_____________________\n\n1 Due to an increased demand for alcohol-based hand sanitizers during the COVID-19 pandemic, the FDA published the Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) on March 19, 2020, and subsequently updated the guidance several times. This guidance communicated the Agency’s temporary policy that we did not intend to take action against firms for CGMP violations under section 501(a)(2)(B) of the FD&C Act if such firms prepared alcohol-based hand sanitizers for consumer use (or for use as a health care personnel hand rub) during the public health emergency, provided certain circumstances described in the guidance were present. These circumstances included preparation of hand sanitizer products using only the ingredients and formulas set forth in the guidance. The guidance was withdrawn effective December 31, 2021 (86 Fed Reg at 56960). Because Global Cosmetics (China) Company Limited’s hand sanitizer products were not prepared under the circumstances described in this guidance, they do not fall within any temporary agency policy not to take action against firms manufacturing hand sanitizer products for violations of section 501(a)(2)(B) of the FD&C Act.","2026-08-20T00:07:04.566+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2024-05-07T13:20:00Z\">05\u002F07\u002F2024\u003C\u002Ftime>\n","\u003Ctime datetime=\"2024-04-30T04:00:00Z\">04\u002F30\u002F2024\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fglobal-cosmetics-company-limited-677948-04302024\">Global Cosmetics Company Limited\u003C\u002Fa>","","2026-08-18T06:42:28.856152+00:00","2026-08-20T02:24:56.037289+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"pma":34,"warning_letter":35},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]