Europe bans Chinese API maker over contamination issues

The European Directorate for the Quality of Medicines has banned products from a Chinese maker of iodine after an inspection at its plant by French inspectors turned up contamination issues in its manufacturing processes, issues with its purified water system and a piece of testing equipment that may have been put in the facility just for show.

In a filing in the European Inspections database, French regulators said they recommended the suspension of the marketing authorization of Huzhou Sunflower Pharmaceutical this month after an inspection in late January of its plant in Huzhou, Zhejiang Province, documented 27 deficiencies, including one critical and four major deficiencies.

Inspectors reported contamination problems in the manufacturing of the povidone iodine that could pose risks to patients. Inspectors noted that employees were filing more than one analysis report on some batches and found "materials and quality documents at a scrap yard outside the main building." There were deficiencies in calibration, as well as other problems in the purified water system.

They said the plant had an IR spectrophotometer that didn't seem to be suitable for use at the facility and that there was "no evidence that the instrument belonged to the inspected site."

This is not the first time that Huzhou Sunflower has had problems with European regulators. The report noted the plant had its certificate of suitability withdrawn in 2012 after refusing to allow inspectors into its facilities.

That is a problem that the FDA has also run into with some Chinese drug manufacturers. The FDA last year banned products from Chinese heparin maker Beijing Shunxin Meihua Bio-technical last year, noting in a warning letter that company officials "repeatedly" refused to let inspectors into the production area or to review records at the facility. The FDA was able to determine that the plant was getting some of its raw materials from a supplier who is on an FDA watch list of suspect companies that don't carefully monitor the source of their materials.

China is the low-cost producer of active pharmaceutical ingredients to the world but Western authorities have tried to step up their own inspections there because of lax oversight by Chinese regulators. The FDA has been trying for several years to get more inspectors based in China but officials have repeatedly blocked their visas. FDA Commissioner Margaret Hamburg, who recently resigned her post, last fall met with officials in China to try to resolve the matter.

- access the notice here