Intrinsic Imaging Undergoes Third FDA Inspection with No 483 Observations

Boston, MA — March 1, 2021 — Intrinsic Imaging, a full-service medical imaging core lab for clinical trials, announces today that it recently underwent an extensive Bioresearch Monitoring Program (BIMO) inspection by the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). This inspection was related to a pivotal study of a novel drug to treat patients with metastatic cancer.

The FDA determined Intrinsic Imaging was in complete compliance with all federal regulations and the company received zero 483 observations.

This was Intrinsic Imaging's third FDA inspection and its third inspection with no findings.

During this successful inspection, the FDA audited Intrinsic Imaging's ISO certified quality management system, standard operating procedures, systems validation, clinical trial documentation, as well as case quality control and primary reviewer and adjudication assessments.