翻译： julia 来源： Julia法规翻译Warning Letter 320-18-38March 5, 2018Mr. Emmanuel Souhaut, PresidentQuali-Controle &Quali-Controle C.E.BAC29 Rue Paul Vaillant-Couturier,Meru 60110, FranceDear Mr. Souhaut:The U.S. Food and DrugAdministration (FDA) inspected your drug contract testing laboratory,Quali-Controle & Quali-Controle C.E.BAC, at 29 Rue Paul Vaillant-Couturier,Meru, from September 14 to 15, 2017.美国FDA于2017年9月14-15日检查了你们位于法国梅吕的合同检测化验室Quali-Controle & Quali-ControleC.E.BAC。This warning letter summarizessignificant violations of current good manufacturing practice (CGMP)regulations for testing finished pharmaceuticals, 21 CFR parts 210 and 211.本警告信总结了制剂检测严重违反CGMP的行为。参见21CFR第210和211部分。Because your methods,facilities, or controls for manufacturing, proce
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