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Wisdom Passed the FDA inspection with no 483



Release Time: 2014-07-18

    In July 2014, Wisdom received the Establishment Inspection Report (EIR) from U.S. Food and Drug Administration (FDA) with the acceptable conclusion of the inspection with no FDA 483 was issued, which showed the advanced quality management concept, religious quality management system and high standard quality management team of Wisdom. It indicates Wisdom has made a great step on the international road.
    From March 31, 2014 to April 4, 2014, the FDA investigator did the comprehensive site inspection and document inspection. The investigator did the evaluation covered on Quality System, Materials System, Facilities and Equipment System, Production System, Packaging and Labeling System and Laboratory Control System professionally, strictly and carefully. Regarding to the questions raised by the investigator, Wisdom team answered factually and detailedly, and provided the corresponding documents and records. Through five days inspection, the inspector announced that no FDA 483 was issued during the inspection in the afternoon of April 4, 2014.
    Behind the success of the inspection with no FDA 483 issued, which was wisdom and courage condensation of all the employees in Wisdom. It is proved that the strict implementation and effective commitment of each stage and key steps was fulfilled in the past three years from beginning of the project, reflected the improvement of the employees GMP concept after continues training and practice. It established a solid foundation for Wisdom to stride towards the international market of APIs.