FDA 483 - Microconstants Inc (DBA BioAgilytix Labs, LLC) - August 29, 2025

An FDA inspection of Microconstants Inc (DBA BioAgilytix Labs, LLC) in San Diego, CA, identified two significant observations related to their nonclinical laboratory operations. The firm failed to establish and follow standard operating procedures for handling test articles and did not adhere to validated sample stability periods. Additionally, the Quality Assurance Unit was found deficient in monitoring studies, detecting transcription errors, and ensuring compliance with GLP regulations.