Transpire Bio, Inc. – FDA 483, Nov 7, 2025

Transpire Bio, Inc., a biopharmaceutical analytical facility, underwent an FDA inspection from November 3 to November 7, 2025. The inspection identified several critical observations related to in vitro bioequivalence (IVBE) studies and associated method validation, indicating deviations from regulatory expectations under the Federal Food, Drug and Cosmetic Act. Key issues included the inaccurate disclosure of all study activities in submitted reports, such as erroneous method validation data and the omission of additional study protocols and data used for bioequivalence evaluations. Furthermore, the company conducted sample analysis for an in vitro rAPSD BE study before completing full method validation. A significant observation also noted the failure to retain adequate reserve samples from all shipments of reference listed drugs used in the IVBE studies, making it impossible to trace which shipments were retained. Transpire Bio, Inc. is required to address these observations promptly by implementing robust corrective actions to ensure data accuracy, proper method validation, and complete sample retention, thereby aligning with FDA regulatory standards.