Current Satus Summary for the__ Deficiency during German EGMP Audit ok.docVIP

Current Status Summary for the Deficiencies during German EGMP Audit Deficiency No. Deficiency Current status Closed Date Proposed Closed date Responsible/Title Deficiency 6.1-1 Deficiencies found at the entrance and the passage for male operator to class B area on the first floor in workshop III. - No instruction of gowning procedure, for example, the prescription what place cloth put on and what operation taken on the room. Closed Jan 1,2009 N/A N/A - No hand-dryer is in usage after washing hands Closed Jan 1,2009 N/A N/A - 1cm distance between the mirror and wall (the wall behind mirror is un-cleanable) Closed Nov 5,2008 N/A N/A - The gowning procedure for class B is not applicable (wear clothes standing on the bench with hands of no gloves taken on) Closed Feb 18,2009 N/A N/A - No sterile packaging is used for clothes of class B area Closed Feb 18,2009 N/A N/A Deficiency 6.1-2 Deficiencies found for entrance to class C for male operators on the 3rd floor in workshop I: - No interlocking system or a visual and/or audible warning system Not closed N/A April 30, 2009 Yang Zhiyun Director of workshop I - Lampshade is not clean Closed Dec 1,2008 N/A N/A - Repeat usage of hand disinfection basin Closed Jan 1,2009 N/A N/A - No hand-dryer is used Closed Jan 1,2009 N/A N/A - No prescription for gowning procedure on site Closed Jan 1,2009 N/A N/A Deficiency No. Deficiency Current status Closed Date Proposed Closed date Responsible/Title Deficiency 6.1-3 Deficiencies found in the weighing room for raw materials of class C filtration area on the 3rd floor in workshop I: - Exhaust grid is not clean Closed Dec 1,2008 N/A N/A - Air is exhausted to the un-classified area Closed Dec 1,2008 N/A N/A - Weigh close to the exhaust grid Closed Dec 1,2008 N/A N/A - No monitoring device for air exchanging or pressure Closed Jan 1,2009 N/A N/A - Less air exchanging frequency and low pressure during audit Closed Nov 4,2008 N/A N/A Deficiency 6.1-4 T