FDA 483 - Transpire Bio Inc. - November 07, 2025

Transpire Bio, Inc. in Weston, FL, a biopharmaceutical analytical facility, was cited for three observations during an FDA inspection. The firm's study reports did not accurately disclose all study activities, including erroneous data reporting and omitted protocols. Additionally, a full method validation was not completed prior to conducting sample analysis for an in vitro bioequivalence study, and the firm failed to retain reserve samples from all shipments of reference standards.