FDA 483 - Pharmaceutical Research Associates, Inc. - September 26, 2025

Pharmaceutical Research Associates, Inc. in Lenexa, KS, a nonclinical laboratory, was issued a Form 483 following an inspection. The observations primarily concern deficiencies in document storage, archiving practices, and the maintenance of study records. Issues included inadequate environmental monitoring for archived GLP studies, delayed archiving of study data, and incomplete master schedule sheets.