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

Source: https://www.keypedia.com/records/483/microconstants-inc-dba-bioagilytix-labs-llc/1dad11ce-473e-4eaf-8764-a30e84abaf03

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

---

## Details

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

## 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/4c118c05-ea3d-4571-a496-62fb6d968628)
- [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