● Parabolic Drugs (APIs), in Haryana, India, cited for “critical and major deviations” involving adequate storage and control of documents and samples and material, falsification of documents and data, and integrity and security of data in the QC laboratory.
● Wuxi Jida Pharmaceuticals (sterile APIs), in Jiangsu Province, Jiangsu City, China, cited for major deï¬ciencies involving sterility assurance and a risk of contamination of the product, “inconsistent and conflicting answers on the same topic from both personnel and management,” and company management non-compliance with gowning procedures during the inspection tour.
● Jinan Jinda Pharmaceutical Chemistry Co. (APIs), in Zhangqiu, China, cited for a “critical deficiency” regarding 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.” Also cited were “major” deficiencies related to training, cleaning validation, breaches of data integrity in the context of HPLC analysis, microbiological laboratory, and qualification of the contract manufacturer of a key intermediate.
● Txcell (cell and tissue therapies), in Besancon, France, cited for aseptic practices, open deviations regarding molds discovered during environmental monitoring (EM), and EM alert limits for clean rooms.
In addition, also in July, Czech health authorities issued a GDP non-compliance statement against a D-Pharm, a distributor in the Czech Republic, stating only that the ﬁrm “does not comply with the Good Distribution Practice requirements referred to in Article 84 of Directive 2001/83/EC.”