Shengli Passes FDA Inspection

Jul 30, 2019

Shandong Shengli Bioengineering passes US FDA inspection with Zero-483

“No findings need to be put on Form 483”. This was the conclusion on July 25, 2019 by the US FDA investigator at the wrap-up meeting after the 4 day general GMP inspection of Shandong Shengli – one of the strategic partners of Rochem International
7月25日,洛比化学的重要战略伙伴 – 山东胜利4天的FDA现场检查顺利结束。在末次会上FDA检查官作出了结论 -本次检查没有任何缺陷需要列入483。

It is the first FDA inspection of Shandong Shengli, the largest manufacturer and exporter of Tiamulin in China and this inspection comes after the filing of the respective VMF#6205 in 2017. This result does not happen easily, especially for a newcomer to regulated markets, under today’s ever increasing regulatory vigilance. “We could not have done this without the tremendous coaching and assistance from Rochem’s professional regulatory and compliance team over the past two years”, the Chairman of Shandong Shengli Mr. Zhang Zhenghai said. It signals a new starting point for the strategic cooperation between Rochem and Shandong Shengli to bring more Shengli products to regulated markets in the future. Matt Thiel, President of Rochem stated, “The success of this inspection will drive not only our Tiamulin business forward but also allows us to accelerate other projects with Shandong Shengli. This result comes from not only the dedication and investment by Shengli’s management, but also from the efforts of our dedicated and skilled regulatory and compliance team who have made a habit out of producing excellent results with our manufacturing partners.”
这是中国最大泰妙菌素生产商和出口商山东胜利在2017美国VMF6205申报后的首次FDA检查。0-483的结果对于一个法规市场的新来者在当今法规监管日益加强的环境下尤为不易。山东胜利党委书记、董事长、总经理张正海先生强调道:“没有这两年来洛比化学专业药政团队的辅导和支持我们不可能取得取得该优异成绩…… “ 这次的检查结果将成为洛比化学和山东胜利后续深化合作的新起点,将有助于山东胜利更多产品进入美国市场。于此,洛比化学总裁麦特先生评论道:“该结果将不仅会直接推进我们的泰妙菌素项目也将加速我们和胜利合作的其它项目;这次的成功一方面是因为胜利管理层的坚定信念和大力投入,另一方面是得益于我们业内一流专业药政团队的不懈努力,因为我们的药政团队总是能够和我们合作工厂伙伴一起共同创造最好结果。“

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