# FDA 483 - OpAns, LLC - August 16, 2019

Source: https://www.keypedia.com/records/483/opans-llc/a7fd7b76-b2d0-4cb3-b249-4ca9f334c724

> FDA 483 for OpAns, LLC on August 16, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OpAns, LLC
- Inspection Date: 2019-08-16
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: 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.

## Related Officers

- [Yiyue C. Zhang](https://www.keypedia.com/people/yiyue-c-zhang/bb9e053e-ff20-4724-b4dc-1ee2e8f23833)

Company: https://www.keypedia.com/companies/opans-llc/dc176b50-d60c-4ef5-b29f-7dcb8231f974

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321