FDA EIR - American Preclinical Services - April 13, 2018

An FDA inspection of American Preclinical Services (APS) in Minneapolis, MN, was conducted from March 19 to April 13, 2018. This for-cause inspection, carried out under the Good Laboratory Practice (GLP) regulatory framework, identified significant systemic deficiencies, resulting in a 4-item FDA 483 observation. Key violations included inadequate oversight by facility management, study directors, and the quality assurance unit. The inspection revealed failures in the proper handling, retention, and labeling of test and control articles, as well as in the execution of GLP study procedures. Issues extended to the review, evaluation, and archival of study data, and the accurate identification of animals, specimens, and reagents. Facility sanitation and water testing practices were also found to be substandard. Additionally, the firm lacked segregation between GLP and non-GLP work and showed inconsistencies in the timely review of operational documents. APS acknowledged the observations and committed to implementing corrections, promising a written response within 15 business days. Required actions include revising documentation practices to ensure quality control reviews, improving animal housing unit identification, and enhancing archival logging procedures. The firm also discussed acquiring a waterless fire suppression system for its largely paper-based archives.