483
Microconstants Inc (DBA BioAgilytix Labs, LLC)FDA 483 - Microconstants Inc (DBA BioAgilytix Labs, LLC)
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Record Details
An FDA inspection of Microconstants, Inc., a bioanalytical laboratory in San Diego, CA, from February 27 to March 3, 2017, identified one observation. The firm failed to properly determine the neutralizing antibody assay cut point in specific studies. This indicates a deficiency in assay validation practices.
- Product Type
- Drugs
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ID · 4c118c05-ea3d-4571-a496-62fb6d968628