FDA 483 - Comparative Biosciences, Inc - April 10, 2026

Comparative Biosciences, Inc. in Sunnyvale, CA, underwent a Good Laboratory Practice inspection that revealed a significant failure by the study director to ensure unforeseen circumstances affecting nonclinical laboratory study quality and integrity were noted and documented with corrective actions. This included instances of test article contamination in multiple studies and repeated freeze-thaw errors. The Quality Assurance Manager also signed compliance statements despite these undocumented issues, indicating serious deficiencies in GLP compliance and data integrity.