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Chinese FDA Releases Report on International Inspections

Chineese “Annual Report of Drug Inspection 2016” has been published by China Food and Drug Administration (CFDA). The report summarizes the results of inspections performed by CFDA in China. Additional report gives an overview of international inspection activities:

The total number of CFDA overseas inspections performed last year was 49 inspections in 19 countries. A number which has been constantly growing over the last years:

Maximum number of inspections (33) was performed in Europe. Six were performed in North America. Countries like Vietnam and India are called "countries with high regional quality risks" in the report. However, only one Indian company was inspected.

Overall, 40 different products ("chemicals") were covered in the inspections, including "injections, solid preparations, implants and nasal sprays".

Observations were noted in Quality Control and Quality Assurance (22 with 6 major deficiencies), Material System and Change Management. Serious deficiencies were mainly noted as "problems in the consistency of production process and data integrity". Deficiencies in local inspections were mainly observed in the areas of Quality Control and Quality Assurance and Documentation Management.


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