FDA 483 - WuXi AppTec Inc. - May 05, 2011

Wuxi Apptec, Inc. in Marietta, GA, a control testing laboratory, was cited for four observations during an FDA inspection. The inspection revealed significant issues primarily related to quality system deficiencies, including inadequate personnel training, insufficient complaint handling procedures, poor documentation and follow-up of corrective and preventive actions, and incomplete quality audit records. These findings indicate a moderate level of non-compliance with quality system regulations.