共计18项缺陷包括

A. 严重缺陷 Critical 2项：

1 Falsification of source of API (Thiamphenicol): Repackaging, relabeling and selling of purchased API from a non-GMP company (Zhejiang Runkang Pharmaceutical Co.Ltd.) as if manufactured in-house
1.原料药甲砜霉素（Thiamphenicol）货源造假，对来自非GMP工厂的API重新包装、贴签后作为本厂生产的API销售；

2. Praziquantel manufactured according to CP process/grade was released as USP process/grade without a full traceability of the testing activities
2.按照中国药典工艺/规格生产的吡喹酮（Praziquantel）作为美国药典工艺/规格放行，检验活动无法完整追溯。

B. 主要缺陷 Major 4项

1. The maintenance and the cleaning operations of the manufacturing line used for the production of Praziquantel (API) were found deficient;
1. 吡喹酮（Praziquantel）生产线的维护和清洁操作存在缺陷

2. The pipes design of some equipment used for the manufacturing of Praziquantel, the handling of change related to these equipment and the instruction used for the transfer of the intermediate solution using nitrogen were found deficient ;
2. 吡喹酮（Praziquantel）生产用的某些设备的管路设计，与这些设备有关的更换处理，以及使用氮气置换中间体溶液的操作指导均存在缺陷

3. The hoses used for unloading of solvent were not identified, had no cleaning status and were stored on a dirty floor of an area not mentioned in the general layout of the site
3.卸溶剂用软管没有标识，无清洁状态，存放在一个工厂布局图中未体现出来的脏地板上

4. There was no procedure in place for audit trail and there was no effective audit trail in place to determine any change or deletion of the chromatographic raw data. The audit trial function including the administrator profiles was enabled for all the QC staff
4. 无审计追踪规程，没有有效的审计追踪来确定色谱原始数据的修改或删除；审计追踪功能，包括管理员权限，对全部QC人员开放。

http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do;jsessionid=D6UUphuK31WD38Apm_06Oy4HSs9WjKF2BL3xu9E8S6xsy5woYa3i!-1831437415?ctrl=searchGMPNCResultControlList&action=Drilldown¶m=33030