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483
•Ibex Preclinical Research, Inc.•May 22, 2026

Ibex Preclinical Research, Inc. – FDA 483, May 22, 2026

Record Details

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.

Company
Ibex Preclinical Research, Inc.
Inspection date
May 22, 2026
Product type
other
Office
Denver District Office
People
  • Courtney R. Bratina (issuing_officer)
  • Audrey J. Yarbrough
  • Erin M. McDowell (other)
View Company Profile

ID · e14d0449-4777-4992-a2a7-8aee72ebd290

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