FDA 483 - Xenobiotic Laboratories, Inc. - March 28, 2025

During an inspection from March 24-28, 2025, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to WuXi AppTec Co., Ltd., operating as Xenobiotic Laboratories, a biopharmaceutical analytical facility in Plainsboro, NJ. The inspection revealed deviations from the company's established Standard Operating Procedures (SOPs) related to the handling of analytical runs for method validation and bioanalytical sample analysis. Specifically, the firm failed to follow its SOP BA 102-04 by reinjecting an entire method validation run after a system communication error, instead of restarting from the last missed sample as required. Furthermore, the company improperly rejected an acceptable study run and reinjected it fully due to internal standard (IS) variation in 45 samples. This was contrary to SOPs BA 102-09 and BA 123-11, which dictate that only affected samples should undergo repeat analysis for IS variation. These observations, issued under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicate practices that need to be addressed to ensure data integrity and compliance. WuXi AppTec is expected to respond to these observations by outlining corrective actions to rectify the identified procedural discrepancies and prevent recurrence, demonstrating adherence to their own quality system and regulatory expectations.