?
ʯ¼ÒׯBOBTY×ÛºÏ|Ê×Ò³¹É·ÝÓÐÏÞ¹«Ë¾
¹ØÓÚÈ«×ÊË﹫˾ͨ¹ýFDAÏÖ³¡¼ì²éµÄ¹«¸æ
±¾¹«Ë¾¼°¶Ê»áÈ«Ìå³ÉÔ±±£Ö¤ÐÅÏ¢Åû¶ÄÚÈݵÄÕæÊµ¡¢×¼È·ºÍÍêÕû£¬Ã»ÓÐÐé¼Ù¼ÇÔØ¡¢Îóµ¼ÐÔ³ÂÊö»òÖØ´óÒÅ©¡£
2022Äê4ÔÂ11ÈÕÖÁ4ÔÂ15ÈÕ£¬Ê¯¼ÒׯBOBTY×ÛºÏ|Ê×Ò³¹É·ÝÓÐÏÞ¹«Ë¾£¨ÒÔϼò³Æ¡°¹«Ë¾¡±£©µÄÈ«×Ê×Ó¹«Ë¾BOBTY×ÛºÏÍòÖÞ¹ú¼ÊÖÆBOBTY×ۺϹÙÍøÓÐÏÞ¹«Ë¾µÄÈ«×Ê×Ó¹«Ë¾±±¾©BOBTY×ÛºÏÉúÎ﹤³Ì¼¼ÊõÓÐÏÞ¹«Ë¾£¨ÒÔϼò³Æ¡°±±¾©BOBTY×ÛºÏÉúÎ£©½ÓÊÜÁËÀ´×ÔÃÀ¹úʳƷBOBTY×ۺϹÙÍøÆ·¼à¶½¹ÜÀí¾Ö£¨ÒÔϼò³Æ¡°FDA¡±£©µÄÏÖ³¡¼ì²é¡£
½üÈÕ£¬±±¾©BOBTY×ÛºÏÉúÎïÊÕµ½FDAÓÚ2022Äê5ÔÂ11ÈÕÇ©·¢µÄÕë¶ÔÕâ´Î¼ì²éµÄÏÖ³¡ºË²é±¨¸æ£¨Establishment Inspection Report£©¡£¸ÃºË²é±¨¸æÈ·ÈÏ£¬±±¾©BOBTY×ÛºÏÉúÎï¿Ú·þ¹ÌÌåÖÆ¼Á³µ¼äÁãȱÏÝͨ¹ýFDAÏÖ³¡¼ì²é¡£¸ù¾Ý¸ÃºË²é±¨¸æ£¬±±¾©BOBTY×ÛºÏÉúÎï¿Ú·þ¹ÌÌåÖÆ¼Á³µ¼ä·ûºÏÃÀ¹úFDAµÄCGMP±ê×¼£¬Í¨¹ýÁËÃÀ¹úFDAÈÏÖ¤¡£
±±¾©BOBTY×ÛºÏÉúÎï±¾´Î˳Àûͨ¹ýFDAÏÖ³¡ÈÏÖ¤¼ì²é£¬±êÖ¾×ű±¾©BOBTY×ÛºÏÉúÎïGMP¹ÜÀí£¨BOBTY×ۺϹÙÍøÆ·Éú²úÖÊÁ¿¹ÜÀí¹æ·¶£©ÒÑ´ïµ½½Ï¸ßˮƽ£¬ÓÐÀûÓÚ¹«Ë¾ÍØÕ¹ÃÀ¹úÖÆ¼ÁÊг¡£¬Ìá¸ß¹ú¼ÊÊг¡¾ºÕùÁ¦£¬¶Ô¹«Ë¾Î´À´¾ÓªÒµ¼¨¾ßÓлý¼«Ó°Ïì¡£
¹«Ë¾ÌáÇë¹ã´óͶ×ÊÕß×¢Òâ£ºÖÆ¼Á³ö¿ÚÒµÎñÈÝÒ×Êܵ½º£ÍâÊг¡»·¾³±ä»¯¡¢»ãÂʲ¨¶¯µÈÒòËØÓ°Ï죬¾´Çë¹ã´óͶ×ÊÕßÀíÐÔͶ×Ê£¬×¢ÒâͶ×Ê·çÏÕ¡£
ÌØ´Ë¹«¸æ¡£
ʯ¼ÒׯBOBTY×ÛºÏ|Ê×Ò³¹É·ÝÓÐÏÞ¹«Ë¾
¶Ê»á
?2022Äê6ÔÂ30ÈÕ