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

Source: https://www.keypedia.com/records/483/microconstants-inc-dba-bioagilytix-labs-llc/4c118c05-ea3d-4571-a496-62fb6d968628

> FDA 483 for Microconstants Inc (DBA BioAgilytix Labs, LLC) on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microconstants Inc (DBA BioAgilytix Labs, LLC)
- Product Type: drugs
- Office Name: Division of Blood Components and Devices
- Summary: 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.

## Related Documents

- [483 - 2017-03-03](https://www.keypedia.com/records/483/microconstants-inc-dba-bioagilytix-labs-llc/2880b6b3-49b2-4714-ab67-1e6329c10b1e)
- [483 - Unknown Date](https://www.keypedia.com/records/483/microconstants-inc-dba-bioagilytix-labs-llc/1dad11ce-473e-4eaf-8764-a30e84abaf03)
- [483 - 2025-08-29](https://www.keypedia.com/records/483/microconstants-inc-dba-bioagilytix-labs-llc/8e8332e9-dc32-42c3-9bbe-702165ceff67)

## Related Officers

- [Melkamu Getie-Kebtie PhD, RPh, Pharmacologist](https://www.keypedia.com/people/melkamu-getie-kebtie-phd-rph-pharmacologist/614a1bb2-1046-48db-b151-3207116a1fe0)
- [Yiyue Zhang, Ph.D., Visiting Associate](https://www.keypedia.com/people/yiyue-zhang-phd-visiting-associate/489c850b-117e-4bd4-b651-c43ffc774c2b)

Company: https://www.keypedia.com/companies/microconstants-inc-dba-bioagilytix-labs-llc/dbf45d41-452a-45f8-9879-6367b5fb1ca4

Office: https://www.keypedia.com/offices/division-of-blood-components-and-devices/02cc5ccf-d21e-445f-91e7-474736bc8917