WuXi AppTec, Inc. – FDA EIR, Sep 7, 2022

An FDA inspection of WuXi AppTec, Inc.'s Saint Paul, MN facility was conducted from August 15 to September 7, 2022, under the Good Laboratory Practice (GLP) regulatory framework (21 CFR Part 58). This was a high-priority follow-up to a previous Official Action Indicated (OAI) classification in 2019, which resulted in 19 inspectional observations. The current inspection aimed to verify the implementation of corrective actions from the 2019 findings. It largely confirmed that significant corrective actions had been implemented, leading to improved procedures and compliance across most areas. However, one significant issue, previously identified, recurred: the company failed to consistently notify all consulting laboratories, contractors, or grantees that studies must adhere to FDA GLP regulations. This was cited as Observation 1 on the FDA 483 form issued to management. Additionally, a verbal observation noted undue client pressure on Study Directors regarding report completion timelines, alongside a lack of clear internal guidance for staff on managing such external influence, though no deficiencies in study conduct were found. Required actions include addressing the repeat observation regarding GLP notification to subcontractors and a commitment from management to review and improve training and procedures for managing client pressure.