FDA 警告信：青霉素交叉污染……

翻译：JULIA  来源：Julia法规翻译Warning Letter 320-19-33             August 6, 2019Mr. Philipp Daniel Haas， Chairman and Chief Executive OfficerDeva Holding AS – Cerkezkoy SubesiHalkali Merkez Mahallesi, Basin Ekspres Cd. No: 1, Kucukcekmece,34303, Istanbul Turkey Dear Mr. Haas:The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Deva Holding AS – Cerkezkoy Subesiat Organize Fatih Bulvar Fatih Bulvar 32 Cerkezkoy, Tekirdag, 59500, Turkey, from February 4, 2019 to February 15, 2019.美国FDA于2019年2月4日至15日检查了你们位于土耳其的Deva Holding AS – CerkezkoySubesi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 ………………………………