OpAns, LLCAugust 16, 2019

FDA 483 - OpAns, LLC - August 16, 2019

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An FDA inspection of OpAns, LLC in Durham, NC, revealed three significant observations related to bioanalysis practices. The firm analyzed and reported results from unsuitable dried blood spot samples and hemolyzed plasma samples without proper assessment. Additionally, plasma samples were stored and analyzed beyond the recommended stability period specified by the commercial ELISA kit.

Company: OpAns, LLC
Inspection Date: August 16, 2019
Product Type: Drugs
Office: International Compliance Team
Person: Yiyue C. Zhang

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ID · a7fd7b76-b2d0-4cb3-b249-4ca9f334c724