On October 31st, China’s National Medical Products Administration (NMPA) announced with immediate effect the suspension of import, sales, and use of Dutasteride Soft Capsules by GlaxoSmithKline (GSK). (See the original announcement here.)
According to the NMPA announcement, during the on-site inspection, GSK failed to comply with China’s regulatory requirements. The inspection found that the company did not conduct batch-by-batch and full item tests as required by China’s registration standards. In addition, there were deficiencies in the prevention and control of microbial contamination risks.
For advisory on complying with China’s GMP and regulatory compliance requirements, Accestra is your professional and reliable partner in all these affairs.
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