CFDA Overseas Inspections

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] China’s FDA (CFDA) has announced the results of its recent overseas inspections of firms importing drugs into China, which includes warnings to firms in Austria, Japan, Italy and India.  Austria’s EVER Neuro Pharma, Japan’s Jiuxin Pharmaceuticals, and Italy’s Bruschettini Laboratories were cited for GMP violations, with inspectors asserting that the actual production processes did not match the firms’ drug registrations.  In addition, Jiuxin’s warning included observations related to its rework processes, process validation, and incomplete testing data, while Bruschettini received observations related to lab data integrity and potential cross-contamination.  India’s Aurobindo “repeatedly” delayed inspections of its cefpodoxime facility, CFDA investigators asserted.   Importation and registration status of some products from these firms will be impacted.  The CFDA notice can be downloaded here (in Chinese).
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