FDA警告信：你们的OOS结果和水系统监测不合格调查系统是不充分的……

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翻译：JULIA  来源：Julia法规翻译 August 1, 2019          Case # 577583       WARNING LETTER            Dear Mr. Ambrose: The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, TG United, Inc., FEI: 3005350897, at 16275 Aviation Loop Drive, from December 17, 2018, to February 15, 2019. 美国 FDA 于 2018 年 12 月 17 日至 2019 年 2 月 15 日检查了你们位于佛州的 TG United, Inc. 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 的行为。参见 21CFR 第 210 与 211 部分。 Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adu ………………………………