We got the inspection report (No.3010163919) sent by US FDA on Oct.28, 2015. The inspection report confirmed that Humanwell Puracap’s softgel production factory passed through the on-site quality inspection of FDA with no defects (The original text is: No FDA 483, Inspectional Observations, was issued). According to the inspection report, Humanwell Puracap’s softgel production factory is in line with the quality standards of CGMP and passes through FDA accreditation. We become the first pharmaceutical enterprise approved by FDA in Hubei Province.
On the afternoon of October 28, Chang’er Zhang, Deputy Secretary of Hubei Provincial Party Committee and leader of Hubei Provincial Leading Group on the Biological Industry, Li Changhai, director of Hubei Food and Drug Administration, Xiao Anmin, deputy director of Hubei Provincial Development and Reform Commission, Zhang Yu, deputy director of Hubei Provincial Commission of Health and Family Planning, Zhang Wentong, director of East Lake High-tech Development Zone, and Dan Changchun, standing deputy director of East Lake High-tech Development Zone and director of Biological Office, came to our plant. They congratulated us on passing through the CGMP without defects and spoke highly of Humanwell Puracap’s production quality, product R&D and enterprise development.
Humanwell Puracap’s passing through FDA without defects this time is good to further expanding the operation scale and optimizing the product structure and will bring positive impact on the company’s exploration in the American market.