PuraCap announced the US Food and Drug Administration (FDA) has completed a successful general inspection of its affiliated soft gelatin capsule manufacturing facility located in Wuhan, Hubei Province China. In addition, a pending ANDA was also recommended for approval as a result of this successful inspection. The inspection confirmed that the site is compliant with Current Good Manufacturing Practices, and no Form 483 observations were issued.
"This is our second successful FDA inspection within two years and the continuation of the planning, development and training necessary to achieve our goal of building a world class pharmaceutical manufacturing facility in China,” Dahai Guo, Chief Executive Officer said. “I am grateful for the tireless work of the Humanwell PuraCap team of manufacturing and quality professionals."