FDA 483 - W. L. Gore & Associates, Inc. - July 26, 2018

W. L. Gore & Associates, Inc. in Flagstaff, AZ, a nonclinical laboratory, received a Form 483 for deficiencies in its quality assurance unit. The inspection revealed that the quality assurance unit failed to adequately monitor studies to ensure conformance with FDA GLP regulations. Specifically, equipment used in studies was misidentified, indicating a breakdown in quality control and data integrity for nonclinical studies.