FDA Raps Chinese API Maker for Quality Failures

The FDA cited WuXi Biologics for multiple quality violations at its Wuxi, Jiangsu site northwest of Shanghai.

The API facility received materials from two vendors that were deemed only “partially satisfactory” according to their performance assessment scores, the FDA investigators found. But WuXi had no written risk assessment or mitigation strategy in place as needed to continue using the suppliers. The company should not have accepted the supplies until corrective actions were taken, the agency said.

The quality unit also took eight months to perform effectiveness checks following multiple complaints. The complaints were closed in July 2018, but effectiveness checks were not conducted until April this year, coinciding with the agency’s inspection.