Topic: manufacturing deficiency
EMA inspectors have uncovered big manufacturing and quality concerns at sterile injectables plant of Genfarma Laboratorio in Spain.
In a warning letter, the FDA shows its dissatisfaction with manufacturing at an Indian API plant in Bangalore for falling short of standards of cleanliness.
When EU regulators last year came down on China’s Jinan Jinda Pharmaceutical for slipshod manufacturing work, the company brought in a U.S. consultant to get its Zhangqiu, Shandong, plant in order. Investigators say its improvement efforts still fall short of what they need to be.