# FDA 483 - Integris Bioservices LLC - August 29, 2025

Source: https://www.keypedia.com/records/483/integris-bioservices-llc/7dedc35a-37f3-4310-a899-890609adb206

> FDA 483 for Integris Bioservices LLC on August 29, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Integris Bioservices LLC
- Inspection Date: 2025-08-29
- Product Type: other
- Office Name: Kansas City District Office
- Summary: Integris Bioservices LLC, a nonclinical laboratory in Olathe, KS, was inspected by the FDA, revealing significant deficiencies. The inspection found issues with data integrity, as raw data for studies could not be reconstructed, and personnel training, where individuals lacked documented training for study protocols and test methods.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/integris-bioservices-llc/114bc71a-2394-42ca-b202-1d48aab68a9f)
- [483 - 2023-10-20](https://www.keypedia.com/records/483/integris-bioservices-llc/79d4824a-8abe-4e6d-800d-57c730adcd40)

## Related Officers

- [Audrey J. Yarbrough](https://www.keypedia.com/people/audrey-j-yarbrough/1bab3d1a-3246-451e-96fb-4ce52185e850)
- [issuing_officer](https://www.keypedia.com/people/courtney-r-bratina/3ad4bfd5-d0da-4801-8e90-a5a3ba9291c3)
- [Carmen Y. Fisher](https://www.keypedia.com/people/carmen-y-fisher/d41b9f1a-1a29-4b1c-bd64-acedde50302a)

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

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79