483
Bioagilytix Labs LLCBioagilytix Labs LLC – FDA 483
Record Details
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.
- Company
- Bioagilytix Labs LLC
- Product type
- biologics
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ID · 2c4cddbf-558e-455f-9d68-3be94d6a281c
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