Ibex Preclinical Research, Inc. – FDA 483, May 22, 2026
Ibex Preclinical Research, Inc. in Logan, UT, was cited for significant deficiencies in its nonclinical laboratory studies, primarily concerning data integrity, protocol adherence, and quality assurance. The inspection revealed failures in accurately recording and verifying experimental data, ensuring proper protocol approval and execution, maintaining adequate standard operating procedures, and managing study archives and final reports. These issues indicate a systemic lack of control over critical aspects of GLP compliance.
ID · e14d0449-4777-4992-a2a7-8aee72ebd290
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