FDA 483 - Wuxi Biologics Co Ltd - April 16, 2019

Wuxi Biologics Co Ltd, a biotech API and sterile finished dose manufacturer in Wuxi, Jiangsu, P.R.C., was cited for four observations during an FDA inspection. The inspection revealed deficiencies in quality control unit procedures for material supplier management, failure to address critical quality attribute trends, insufficient reserve sample retention, and inadequate analytical method evaluation. These issues indicate a lack of robust quality systems and control over manufacturing processes.