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

During an inspection from August 25-29, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Microconstants Inc (DBA BioAgilytix Labs, LLC) following observations at their San Diego nonclinical laboratories. The inspection revealed significant issues indicating non-conformance with Good Laboratory Practice (GLP) regulations.

The primary violations included a lack of established standard operating procedures for the receipt, identification, storage, handling, mixing, and sampling of test and control articles. Specifically, study samples for protocol MC18I-0016 exceeded their validated stability periods, and no deviation was initiated or reported, despite internal procedures requiring such actions.

Additionally, the Quality Assurance Unit (QAU) failed in its responsibility to monitor studies effectively and ensure adherence to FDA GLP regulations. The QAU did not detect analyst transcription errors resulting in incorrect inventory volumes, nor did it identify instances where analysts bypassed Computer System Problem Reporting procedures. Furthermore, the QAU lacked sufficient audit trail monitoring and review activities to detect procedural bypasses.

While the FDA 483 documents observations rather than prescribing specific actions, Microconstants Inc is required to investigate these deficiencies, determine their root causes, and implement comprehensive corrective and preventive actions to ensure full compliance with FDA GLP regulations.