L'ANSM sanctionne un fabricant chinois

Ce rapport de non conformité de l'ANSM publié sur le site EUDRAGMDP mentionne plusieurs écarts critiques et majeurs liés à la Data Integrity :
Nature of non-compliance : Overall around 22 deficiencies were observed, out of which one was classified as critical and three as major // Critical: manipulation, backdating and falsification of GMP documents such as batch manufacturing record, report of starting material manufacturer audit, GC and HPLC chromatograms. // Major 1: undeclared workshop without any traceability of the activities underaken. // Major 2: undeclared storage of unidentified product without any traceability. // Major 3: poor standards for issuance of batch manufacturing records.
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