12.03.2010 • News • Food and Drug Administration (FDA) • Active Pharmaceutical Ingredients (APIs) • cGMP

ChemWerth to Rebuild Quality Systems for Xi’An Libang Pharmaceutical

Xi'An Libang Pharmaceutical (Xi'An, China) said it has appointed ChemWerth as their consultant for the purpose of responding to an U.S. 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 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 Xi'An Libang staff. He brings over 14 years of experience working at the FDA and has been instrumental in conducting customer driven, six-system audits, FDA inspections, and installing cGMP improvement programs at several Chinese factories.

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