483
Integris Bioservices LLCIntegris Bioservices LLC – FDA 483, Aug 29, 2025
Record Details
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.
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ID · 7dedc35a-37f3-4310-a899-890609adb206
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