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FDAnews Drug Daily Bulletin

EU Urged to Suspend License of Chinese API Maker

Aug. 8, 2016

Spanish regulators are recommending that EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant.

The recommendation by the Spanish Agency of Medicines and Devices asserts that Jinan Jinda Pharmaceuticals’ facility in Shandong, China, has been in violation of EU GMP standards since June 2015. An inspection at the time uncovered multiple GMP deficiencies, findings that were reaffirmed by Spanish authorities when they re-inspected the site.

All told, the company racked up 30 deficiencies over the course of two inspections, two of which were deemed critical and eight considered major deficiencies. Deficiencies include data safety and control, training, quality assessment and validation methods.

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