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

This FDA Form 483 was issued to Zhisheng Chen, CEO of Wuxi Biologics Co Ltd, located at 108 Meiliang Road, Binhu District, Wuxi, Jiangsu, P.R.C. 214092. The inspection, conducted from April 8 to April 16, 2019, identified observations at this biotech API and sterile finished dose manufacturer.

Key observations include: 1. **Quality System - Material Supplier Management:** The firm did not fully follow procedures for material supplier management. Specifically, WX-SOP-00451-14 Section 4.3.12.2.C, which states "Partially satisfactory, no supply until corrective actions in place" for suppliers scoring between [b] (4) and [b] (4), was not adhered to. A critical supplier, [b] (4), received such scores for 2017 and 2018 assessments, yet the firm continued to receive lots. At least seven complaints related to leaking disposable bags, including [b] (4) bags used in [b] (4) drug substance production, were filed with [b] (4) in 2017 and 2018. No formal closure of corrective actions, written risk assessment, or mitigation strategy for continued use of this supplier was identified.

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