FDA 483 - Transpire Bio Inc. - October 01, 2025

Transpire Bio Inc., a manufacturer of dry inhalation drugs in Weston, FL, was cited for significant quality control and documentation deficiencies during an FDA inspection. Observations included the failure of the quality unit to review audit trails before product release, inadequate quarantine procedures for incoming materials, and poorly designed equipment logbooks leading to inconsistent and missing batch information. These issues indicate a lack of robust control over manufacturing processes and data integrity.