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[变更管理] 07月收到FDA警告信的企业

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药徒
发表于 2014-7-31 12:49:15 | 显示全部楼层 |阅读模式

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本帖最后由 道路漫长黑暗 于 2014-7-31 16:47 编辑

2014 Warning Letters仍有中国企业上榜
注:点击Company Name 可直接阅读
[td]
Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
July 22, 2014K-Fat Inc.New York District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *
July 22, 2014Hoke FarmsPhiladelphia District OfficeUnapproved New Animal Drug/AdulteratedNot Issued *
July 21, 2014Med-Mizer, Inc.Detroit District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *
July 21, 2014Smoker Friendly International LLCCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *
July 18, 2014PharMEDium Services, LLCChicago District OfficeCompounded Drugs/CGMPNot Issued *
July 17, 2014Schindele Enterprises dba Midwest WholesaleKansas City District OfficeUnapproved/Misbranded drugsNot Issued *
July 17, 2014Opada Alzohalli, M.D.Center for Drug Evaluation and ResearchClinical InvestigatorNot Issued *
July 17, 2014Klein Laboratories, Inc.New England District OfficeUnapproved New Drug/AdulteratedNot Issued *
July 16, 2014National Cigar StoreCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *
July 15, 2014C P Health Products Inc.New York District OfficeCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
July 15, 2014Graham Shrimp Co., Inc.New Orleans District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *
July 15, 2014Yellowstone Tobacco Co, LLC.Center for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *
July 15, 2014Dueppengeisser Dairy CompanyNew York District OfficeIllegal Drug ResidueNot Issued *
July 15, 2014Trivett SalesCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *
July 14, 2014Noni Connection dba Puna NoniSan Francisco District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *
July 14, 2014Abrams Royal PharmacyDallas District OfficeCompounding Pharmacy/Adulteration/MisbrandingNot Issued *
July 14, 2014RC Compounding Services, LLCCincinnati District OfficeInsanitary Conditions/AdulteratedNot Issued *
July 14, 2014Smoker FriendlyCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *
July 10, 2014Todd & Patty Meech Dairy FarmMinneapolis District OfficeIllegal Drug ResidueNot Issued *
July 10, 2014Diamond W RanchSan Francisco District OfficeIllegal Drug ResidueNot Issued *
[td]
Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
July 09, 2014www.200cigarettes.bizCenter for Tobacco ProductsFamily Smoking Prevention and Tobacco Control Act/Adulterated/MisbrandedNot Issued *
July 09, 2014Zhejiang Jiuzhou Pharmaceutical Co., Ltd.Center for Drug Evaluation and ResearchCGMP/Active Pharmaceutical Ingredient (API)/AdulteratedNot Issued *
July 07, 2014JCB Labs LLCKansas City District OfficeCompounding Pharmacy/Adulteration/MisbrandingNot Issued *
July 07, 2014Trifarma S.p.A.Center for Drug Evaluation and ResearchCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
July 03, 2014Easy Moon, Inc. - Ramona Egg RanchLos Angeles District OfficePHS Act/Shell Egg Regulation/AdulteratedNot Issued *
July 03, 2014Solace International, Inc.San Francisco District OfficeUnapproved New Drug/MisbrandedNot Issued *
July 03, 2014Walker's Food Products CoKansas City District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *
July 03, 2014Double D DairyDetroit District OfficeUnapproved New Animal Drug/AdulteratedNot Issued *
July 02, 2014Ventlab LLCDetroit District OfficeCGMP/QSR/Medical Devices/AdulteratedNot Issued *
July 02, 2014Sterling Heights Dairy Farm LLCCincinnati District OfficeIllegal Drug ResidueNot Issued *
July 02, 2014Central SoyfoodsKansas City District OfficeCGMP/Food/AdulteratedNot Issued *

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大师
发表于 2014-7-31 13:29:42 | 显示全部楼层
持续改进。
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药徒
发表于 2014-7-31 13:31:40 | 显示全部楼层
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药徒
发表于 2014-7-31 13:36:08 | 显示全部楼层
九洲药业负面影响还是较大的。
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发表于 2014-7-31 13:40:19 | 显示全部楼层
正常情况,谁都会犯错,关键 犯错之后怎么改。
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药徒
发表于 2014-7-31 14:42:31 | 显示全部楼层
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发表于 2014-7-31 14:49:21 | 显示全部楼层
能不能翻译下啊,楼主
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药徒
发表于 2014-7-31 14:56:01 | 显示全部楼层
看懂了浙江九州 {:soso_e147:}
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药徒
发表于 2014-7-31 16:46:21 | 显示全部楼层
最好问题写出来
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药徒
 楼主| 发表于 2014-7-31 16:46:58 | 显示全部楼层
JIAOZHX 发表于 2014-7-31 16:46
最好问题写出来

亲,点击企业名称可以直接查看警告信内容
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