Resumo da Carta de Não Conformidade para o fabricante Chinês JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD. com site de produção em No. 6121 Longquan Road, Zhangqiu, Shandong Province, 250 200, China:
In total 18 deficiencies were identified by the inspection team, one of them was classified as critical and six as major. The critical observation was related to an unofficial and non-controlled storage area containing mainly raw materials and finished products which had been made inaccessible to inspectors as the door had been removed and replaced with a panel fixed with screws to the wall, which during the inspection the Company was requested to remove. The material stored in this area was to be managed outside of the Quality Assurance system and the investigation carried o ut by the inspection team concluded there was a serious risk of data falsification. One of the six major deficiencies was related to a very similar issue, as access to a locked garage was given to the inspection team only hours after requesting it. In both cases the explanations provided were not sound and different versions were given during the inspection. The remaining five major deficiencies were related to specific aspects of the Quality Assurance System with regards to training, cleaning validation, breaches of data integrity in the context of HPLC analysis, microbiological laboratory, qualification of contract manufacturer of a key intermediate of Nitrofurantoin production.
Produtos fabricados no site:
Foscarnet Sodium, Rosuvastatin Calcium, Carprofen, Dantrolene Sodium, Trospium chloride, Nitrofurantoin, Nitrofurantoin Macrocrystals, Nitrofurantoin Monohydrate, Tolperisone hydrochloride, Nitrofu razone (FDA), Furazolidone, Feprazone, Cyclandelate, Phenylbutazone, Haloperidol, Clozapine, Carbamazepine, Berberine Tannate, Methylbenactyzine Bromide, (+)-Sotalol Hydrochloride, Dipyridamole, Cimetidine, Allantoin, Bifendate, 1-Aminohydantoin, 1-Aminohydantoin Hydrochloride, Laurocapram, Foscarnet Sodium Hexahydrate, Bromfenac Sodium, Cidofovir Dihydrate, Racecadotril, Florfenicol.