483
Microconstants Inc (DBA BioAgilytix Labs, LLC)Microconstants Inc (DBA BioAgilytix Labs, LLC) – FDA 483, Aug 29, 2025
Record Details
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.
- Inspection date
- August 29, 2025
- Product type
- biologics
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ID · 8e8332e9-dc32-42c3-9bbe-702165ceff67
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