FDA EIR - WuXi Advanced Therapies - January 22, 2020

An FDA surveillance inspection of WuXi Advanced Therapies, located in Philadelphia, PA, took place from January 14 to January 22, 2020. Operating as a contract manufacturer of biological cell banks and a contract testing laboratory for biotech drug products, the company was assessed under Compliance Program 7356.002 M, focusing on Inspections of Licensed Biological Therapeutic Drug Products and adherence to Current Good Manufacturing Practices (CGMP) across Quality, Laboratory Control, and Production Systems. While no formal FDA Form 483 was issued during this inspection, two key observations were discussed with management. First, there was a noted deficiency in the company's communication and the currency of its Quality Agreements with customers, leading to uncertainty regarding the precise scope of testing responsibilities for commercially approved drug products. Second, inspectors identified inadequate sanitization procedures within microbiology hoods, specifically citing insufficient contact time for sanitizing solutions and sub-optimal wiping techniques, which raised concerns about maintaining aseptic conditions. WuXi Advanced Therapies' management acknowledged these issues during the closeout meeting. Required actions involve improving and updating quality agreements to ensure clarity with clients and revising sanitization procedures for microbiology hoods to ensure effective microbial control. Management confirmed that their quality team was actively evaluating necessary procedural changes to address these observations.