2011?6?7??10?,??????????????????????????FDA????Douglas A. Campbell???????GMP??(Preapproval Inspection, PAI)?
????????(6?7?),????????????????????,??????????;????????,?????????????????;??????????????????????????????????,Campbell?????????????,???????????
???(6?8?)??,Campbell????????????????,??????????????????????,??????????????????????,????FDA�?????????�???Campbell????????????????,????????????????,?????????棗???????????????????,?????????????????Campbell???????????????????????,Campbell?????????????,??????????????,????????,??????????????,?????????,????????????FDA??????????????,???????????????????,???????????????????
???(6?9?),Campbell???????????????????????????,?????????????????,??????,??????????,?????????????????????�????�?????????????????????????,????????????????????,??????????????????????????????,Campbell?????????????????????,???????????????FDA??????????????,??,????????????????????????
???(6?10?)??,?????????????Campbell???????????????????????,??????????????????????????,???????????????????
????????????Campbell???,????????GMP????????????,???GMP???????????????????GMP?????????????,??????;??????????????FDA????????�??????�,????????????FDA????GMP?????????????,�????????GMP???,??????????FDA??????????????�,Campbell?????????,?????????,�?????????????????????????,??????????,?????GMP?????FDA???� ???Campbell????????????,??????????????????????????,????????????,�????????GMP????????�?????????????GMP????????,?????????
2011?9?16?,FDA?????????????????????????????????????GMP????????????????????!