The action began in June 2015 when EU regulators clamped down on the active pharmaceutical ingredient (API) producer for inferior manufacturing. Problems were discovered following an inspection of their plant in Zhangqiu, Shandong, which produces nitrofurantoin, an antibiotic commonly used to treat bladder infections.

The inspection revealed 18 deficits and concluded that there was a serious risk of data being falsified, leading the European Directorate for the Quality of Medicines (EDQM) to suspend its certificate of suitability for nitrofurantoin.

Soon after, Jinan Jinda brought in US consultant ChemWerth – a generic API development and supply specialist – to fix the problems and help the company return to the European market. However, a recent follow up by the Spanish Agency of Medicines and Medical Devices found that the company was still shipping the antibiotic to some European customers, despite not meeting the standards required by the EU.

The check-up, a year on from the initial inspection, showed that the list of problems at the plant had grown from 18 to 30. Eight of these were classified as major (including problems in training, quality assessment and cleaning) and two as critical (including how the plant handles raw data).

The Spanish investigators acting on behalf of EMA reported that the company had not implemented corrective and preventive actions in a satisfactory manner, and was still not in compliance with Good Manufacturing Practice (GMP).
As such, the EDQM recommended that the antibiotic produced by Jinan Jinda be banned from the EU and that the plant’s certificate of compliance be suspended or perhaps even voided. The full statement can be found on the EMA’s database for manufacturers authorizations and GMP certificates, EudraGMDP.

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