# FDA 483 - Microconstants Inc (DBA BioAgilytix Labs, LLC) - August 29, 2025

Source: https://www.globalkeysolutions.net/records/483/microconstants-inc-dba-bioagilytix-labs-llc/8e8332e9-dc32-42c3-9bbe-702165ceff67

> FDA 483 for Microconstants Inc (DBA BioAgilytix Labs, LLC) on August 29, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Microconstants Inc (DBA BioAgilytix Labs, LLC)
- Inspection Date: 2025-08-29
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Microconstants Inc (DBA BioAgilytix Labs, LLC) in San Diego, CA, identified two significant observations related to their nonclinical laboratory operations. The firm failed to establish and follow standard operating procedures for handling test articles and did not adhere to validated sample stability periods. Additionally, the Quality Assurance Unit was found deficient in monitoring studies, detecting transcription errors, and ensuring compliance with GLP regulations.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/humberto-z-gomez/6de682f6-ae2a-45ff-92ab-ba6ac7bb97b4)
- [Scott N. Lim](https://www.globalkeysolutions.net/people/scott-n-lim/d5e7745a-d804-48d1-8f3b-a94a8d4aed8a)

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b