FDA 483 - Geneva Laboratories, Inc - July 23, 2021

An FDA inspection of Geneva Laboratories, Inc. in Elkhorn, WI, a nonclinical laboratory, revealed multiple deficiencies in their operations. The firm failed to adhere to GLP regulations concerning quality assurance monitoring, personnel training, resource availability, equipment maintenance, and proper archiving of study data. These issues indicate a significant lack of control over critical aspects of nonclinical laboratory studies, potentially compromising data integrity.