Geneva Laboratories, Inc – FDA 483, Apr 5, 2018

Geneva Laboratories, Inc. in Elkhorn, WI, underwent a GLP BIMO inspection from March 28 to April 5, 2018. The inspection revealed four significant observations related to inadequate equipment validation, insufficient quality assurance unit oversight of nonclinical studies, unqualified personnel signing off on GLP studies, and a lack of independence within the Quality Assurance Unit's reporting structure. These issues indicate deficiencies in the firm's adherence to Good Laboratory Practice regulations.