FDA警告信：法国Biologique Recherche (B.R.) SAS

 翻译：JULIA 来源：Julia法规翻译 Warning Letter 320-18-57June 8, 2018 Mr. Pierre-Louis Delapalme, Co-PresidentBiologique Recherche (B.R.) SAS28 rue de la Procession, Suresnes,92150 France Dear Mr. Delapalme:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Biologique Recherche (B.R.) SAS at 28 rue de la Procession, Suresnes, from September 18 to 22, 2017.美国FDA于2017年9月18-22日检查了你们位于法国苏雷斯尼的Biologique Recherche (B.R.) SAS生产场所。This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.本警告信总结了制剂生产严重违反CGMP要求，以及制剂生产严重违反CGMP法规21CFR第210和211部分的行为。Because your methods, facilities, or controls formanufac ………………………………