Tuesday, March 31, 2015

Europe bans Chinese API maker over contamination issues March 31, 2015 | By Eric Palmer

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. more

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