Drug Administration overseas sword, checked five medical equipment companies
Pharmaceutical Network November 29 According to the State Administration of Drug Control WeChat official 'Chinese Food News' message, the State Administration of Drug Control has 5 medical equipment manufacturing enterprises conducted overseas production site inspection.
In 2017, the General Administration of China Administration of Drug Administration again swords, medical equipment GMP Compliance inspection not only for domestic production enterprises, but also for overseas manufacturing enterprises.
According to the circular, all five foreign enterprises were found to have defects in the quality management system, with more or fewer problems.
Five companies have also been accused of rectification within a time limit, while assessing product safety risks, may cause potential safety problems, according to the provisions of the recall of related products.
In addition based on the national earlier this year medical instruments Supervision and management work conference, 2017 Drug Administration in total planned to organize 20-30 overseas enterprise After carrying out on-site verification of the production site, more inspection results of overseas machinery enterprises may be announced.
The following five companies were found the results:
1, on the Beckman Coulter, Inc. overseas production site inspection results notification
