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Foreword

The Center for Food and Drug Inspection (CFDI) organized to conduct a total of 431 inspections throughout the year, including pre-approval inspection, GMP certification inspection, GMP follow-up inspection, unannounced inspection, overseas inspection , GSP unannounced inspection and inspection observation.


Overview of Inspections


A total of 29 inspection tasks were received in 2016, of which 21 tasks were from the Center for Drug Evaluation of CFDA (hereinafter referred to as CDE), 8 tasks were from the Department of Drug and Cosmetics Registration of CFDA and discipline inspection and supervision departments (for-cause inspection tasks). A total of 178 person-times, 43 inspection teams have been sent out to conduct pre-approval inspection on 34 varieties; 42 on-site inspection reports have been completed, of which 34 passed the inspection, accounting for 81%; and 8 failed or proactively withdrew registration applications, accounting for 19%.


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