An inspection at one of the manufacturing sites involved in the valsartan contamination investigation has found that the facility did not comply with good manufacturing practice (GMP). As a result, the site is no longer authorised to produce valsartan or its intermediates for the European Union (EU).
The site inspection, carried out by the European Medicines Agency (EMA) and the European Directorate for the Quality of Medicines and Healthcare (EDQM), forms part of the EMA review of patient risk arising from the identification of sartan products contaminated with the probable human carcinogens N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
Although the EMA review has now been extended to include other sartan products, this latest inspection focused on the manufacture of valsartan at the Zhejiang Huahai Chuannan site in Linhai, China. It found “several weaknesses” at the facility, including deficiencies in the way the company investigated the presence of NDMA and NDEA in its valsartan products.
The site has recently also been inspected by the US Food and Drug Administration (FDA), which has issued an alert prohibiting all active substances produced by Zhejiang Huahai’s Chuannan facility and all medicines containing the active substances from entering the United States.
The EMA review is ongoing.