FDA 483 - Microconstants Inc (DBA BioAgilytix Labs, LLC) - March 03, 2017

From February 27 to March 3, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of Microconstants, Inc., a bioanalytical laboratory located in San Diego, California. The inspection, conducted under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, resulted in the issuance of Form FDA 483. The primary concern identified during the assessment involved the methodology for neutralizing antibody assays. Specifically, the FDA investigators observed that the laboratory did not use samples from drug-naive subjects to determine the assay cut point. This deficiency is significant because establishing a baseline from subjects who have not previously been exposed to the drug is a critical step in ensuring the accuracy and reliability of the assay results. While the Form 483 represents the investigators" observations and not a final agency determination of compliance, Microconstants, Inc. is expected to respond. Required actions include discussing any objections to the findings or submitting a detailed plan of corrective actions to the FDA. This response must address how the firm will rectify the methodology to ensure that future bioanalytical data meets the necessary standards for clinical study integrity.