FDA 483 - Pacific BioLabs - July 18, 2025

An FDA inspection of Pacific Biolabs, Inc. in Hercules, CA, a nonclinical laboratory, revealed significant deficiencies in documentation, data integrity, and quality assurance practices. Observations included failures to characterize test articles and challenge agents, conduct dose formulation analyses, document protocol deviations, and accurately record experimental data and material quantities. These issues indicate a lack of control over critical aspects of nonclinical studies.