ChemWerth to Rebuild Quality Systems for Chinese Pharma Company
Xi’An Libang Pharmaceutical, Xi’An, China, has appointed ChemWerth as their consultant for the purpose of responding to an US Food and Drug Administration (FDA) warning letter.
Jeffery Hangartner, a former FDA investigator who now heads a regulatory team for ChemWerth in China, will serve as an independent, third party auditor who is responsible for overseeing the rebuilding of the Xi’An Libang quality system.
Hangartner will also be responsible for conducting a current Good Manufacturing Practice (cGMP) training program for the Chinese company's staff.