FDA 483 - Wuxi Biologics Co Ltd - April 02, 2021

This FDA Form 483 details multiple observations from an inspection.

**Computer System Controls:** The facility lacks adequate controls over computer systems. Procedure WX-SOP-00154 for the Process Automation System (b)(4) Batch (b)(4) requires QA approval for parameter modifications but not verification of accuracy post-change. Second-person verification is required but not always performed, as evidenced by missing signatures for an alarm limit change on 02/08/2021. This led to Deviation DV39507 for (b)(4) Lot (b)(4), requiring reprocessing.

**Quality Unit Oversight:** The Quality Assurance department has deficient oversight of controlled document issuance. There are inadequate controls for the distribution and reconciliation of quality forms. For example, Form WX-FORM-000970-09 (Registration Form for Samples for Analyses) lacks an adequate reconciliation plan, and Form WX-FORM-002218-02 (Incoming Material Checklist) is issued by the Warehouse Documentation group without QA oversight.

**Preventative Maintenance:** Adequate preventative maintenance schedules are not established for equipment, specifically (b)(4) (MFG-UOE-3290), (b)(4) (MFG-DFC-3016), and (b)(4) (MFG-DFC-3017). WX-SOP-0