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Intrinsic Imaging Undergoes Third FDA Inspection with No 483 Observations

Intrinsic Imaging recently underwent an extensive inspection by the U.S. Food and Drug
Administration (FDA). 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.

Boston, MA, March 01, 2021 --(PR.com)-- 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.

“Our quality management system is one of the most comprehensive and sophisticated in the industry,”
said Todd A. Joron, BSc, MBA, President & COO at Intrinsic Imaging. “This successful audit bears
testament to our continued commitment to quality.”

Certified by the British Standards Institute (BSI), Intrinsic Imaging is the only company in the world to
hold five ISO certifications specifically for providing imaging core lab services on clinical trials. Intrinsic
Imaging’s quality management system is certified to the following standards:

ISO 9001 - Quality Management Systems for Phase I-IV clinical trials
ISO 13485 - Quality Management Systems for Class I-III medical device trials
ISO 22301 - Business Continuity Management System
ISO 27001 - Informational Security Management System
ISO 27018 - Protection of Personally Identifiable Information on the Cloud

“We are very pleased with the results of this most recent FDA inspection and we look forward to
continuing to provide quality services to all of our clinical trial Sponsors,” said Bryan Wayne, Vice
President, Imaging Operations at Intrinsic Imaging.

About Intrinsic Imaging, LLC


Intrinsic Imaging is a full-service medical imaging core lab providing comprehensive services in support
of Phase I-IV clinical trials and Class I, II, III medical device trials. Its team consists of more than 600

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board-certified and fellowship-trained physicians. Intrinsic Imaging’s team has sub-specialization in all
therapeutic areas including cardiology, central nervous system, gastroenterology, musculoskeletal,
oncology and ophthalmology. Certified by the British Standards Institute (BSI), Intrinsic Imaging is the
only company in the world to hold five ISO certifications specifically for providing imaging core lab
services on clinical trials. With our medical expertise, operational excellence and ISO-certified quality
management systems, Intrinsic Imaging is ideally positioned to provide imaging core lab services to
clients worldwide.

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Contact Information:
Intrinsic Imaging, LLC
Todd Joron
978-634-2201
Contact via Email
IntrinsicImaging.com

Online Version of Press Release:


You can read the online version of this press release at: https://www.pr.com/press-release/831991

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