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

During an inspection from February 27 to March 3, 2017, Microconstants, Inc. in San Diego, CA, a bioanalytical laboratory, was cited for an issue related to their neutralizing antibody assay. Specifically, the cut point for this assay in several studies was not determined using samples from drug-naive subjects, indicating a potential deficiency in assay validation or methodology.