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. But a recent follow-up found that Jinan Jinda continues to ship its antibiotic to some European customers even though its improvement efforts fall short of what they need to be.
In an enforcement report filed this week, the European Directorate for the Quality of Medicines (EDQM) said it has been recommended that Jinan Jinda's nitrofurantoin antibiotic be banned from the EU and that the plant's certificate of compliance be suspended, or even “voided.”
When Italian inspectors checked out the plant in June 2015, they tallied 18 deficiencies. Among other serious concerns, they said they found raw supplies and finished products in a room in which the door had been screwed shut by employees. They "concluded there was a serious risk of data falsification" related to the ingredients in the room.
Weeks later, the API maker announced it had hired Connecticut-based ChemWerth to help it get its processes up to EU standards and hoped to reapply for its certificate within a year.
It was inspectors from Spain who checked out the plant in June of this year on behalf of the European Medicines Agency to see how Jinan was progressing. They said the list of problems has now grown to 30 deficiencies, two of them classified as critical and 8 more as major. The investigators reported that the company’s corrective and preventive actions (CAPA) for problems uncovered in the June 2015 inspection "‘were found as not having been implemented in a satisfactory way,” they said.
The investigators reported that there were critical deficiencies in the way the plant handled raw data safety, control and out-of-specification reviews. There were major deficiencies in training, change control, quality assessment, process and cleaning validations.
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