# FDA 483 - Integris Bioservices LLC - October 20, 2023

Source: https://www.keypedia.com/records/483/integris-bioservices-llc/79d4824a-8abe-4e6d-800d-57c730adcd40

> FDA 483 for Integris Bioservices LLC on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integris Bioservices LLC
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: KCAS Bioanalytical & Biomarker Services in Olathe, KS, a biopharmaceutical analytical facility, was inspected from October 16-20, 2023. The inspection revealed significant issues with data integrity and reporting practices related to sample analysis. Specifically, the firm failed to report all reanalyzed samples and did not accurately document study activities and information in bioanalytical reports.

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## Related Officers

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

Company: https://www.keypedia.com/companies/integris-bioservices-llc/1f2e0885-338c-49d4-9afd-14924079d628

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd