FDA actions taken against Indian drugmakers have grabbed a lot of attention in recent years, but Europe has also been pushing foreign suppliers to hit higher standards. Each country does its own inspections but then shares any issues it finds through a common website. Most recently, Italy flagged problems with three plants, two in China and one in India.
According to reports posted on the EudraGMDP site, regulators from Italy recommended bans on specific products made by Jinan Jinda Pharmaceutical in Shandong Province in China and Wuxi Jida Pharmaceutical in Jiangsu City, China, as well as Parabolic Drugs in Haryana, India.
In the case of Jinan Jinda, the regulators were looking at the API for the antibiotic nitrofurantoin. It also said Jinda should not be granted any future approvals until issues are resolved. Those issues included 18 deficiencies, one which was classified as critical and 6 as major.
"The critical observation was related to an unofficial and noncontrolled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors," regulators said. Inspectors "concluded there was a serious risk of data falsification" related to the ingredients in room, the door of which had been screwed shut by employees.
For Wuxi Jida, inspectors were taking a look at sterile glutathione rinsing solution. In the unit that they inspected, they found 28 deficiencies, 15 of which were rated as major. Many of those raised questions about the possibility for contamination, including workers wearing inappropriate clothes, inadequate pressure seals to keep clean rooms safe and unsealed shipping tins. Again, "ambiguous" documentation was often provided.
Finally, the issues at Parabolic Drugs had to do with the antibiotic dicloxacillin sodium. At this plant, inspectors for the Italian Medicines Agency (IMA) documented 27 deficiencies, three it considered critical. At Parabolic there also were questions of data falsification and inadequate storage and control of documents and samples and material, among others.
In each case, the IMA authorities suggested the specific products be banned and recalls be considered by each country which may have them in their supply chain.
The IMA findings were not unlike what the FDA uncovered at Indian drugmaker Mahendra Chemicals in Gujarat, India, where it discovered approvals were sometimes forged and documents backdated. This week, the FDA posted a warning letter sent to the company earlier this month.
- access the reports here