China – Third Form 483 Surfaces for China Company at Center of Valsartan Contamination

Just days since FDA, EMA and Health Canada announced that a second impurity, called N-nitrosodiethylamine (NDEA), has been found in valsartan manufactured by Zhejiang Huahai Pharmaceuticals and FDA has released a third Form 483 for the company.

Following inspections in July and August, FDA issued the 483 with 11 observations, with specific issues raised about the firm’s quality unit.

“The system for managing quality to ensure confidence that the API [active pharmaceutical ingredient] will meet its intended specifications for quality and purity is not adequate in that your quality unit lacks written procedures and the authority and responsibility to ensure all critical deviations are thoroughly investigated,” the 483 released on Thursday says…