# Bioagilytix Labs LLC – FDA 483

Source: https://www.keypedia.com/records/483/bioagilytix-labs-llc/2c4cddbf-558e-455f-9d68-3be94d6a281c

> FDA 483 for Bioagilytix Labs LLC on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bioagilytix Labs LLC
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of BioAgilytix Labs LLC, a biopharmaceutical analytical facility in Durham, NC, revealed a significant data integrity issue. The firm was cited for incorrectly conveying mean electrochemiluminescence (ECL) and % Coefficient of Variation (CV) values in a study report submitted to the FDA. This indicates discrepancies between reported data and site source records.

## Related Officers

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Company: https://www.keypedia.com/companies/bioagilytix-labs-llc/5ad61c91-b0e2-4d98-8764-f97c5a9f42c7

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4