Quality
FDA Audited
Intrinsic Imaging has successfully completed three FDA inspections spanning both medical device and pharmaceutical clinical trials, with each inspection concluding with zero Form FDA 483 observations. This consistent regulatory performance demonstrates the strength and effectiveness of our Quality Management System, operational controls, documentation practices, and commitment to data integrity.
Our inspection history reflects a culture of quality embedded throughout our organization and our ability to consistently operate within rigorous regulatory requirements. From imaging acquisition and data management to independent image review and study documentation, our processes are designed to support inspection readiness and maintain the highest standards of quality and compliance throughout the clinical trial lifecycle.
| FDA Inspection #1 | FDA Inspection #2 | FDA Inspection #3 |
|---|---|---|
| August 2012 | August 2018 | January 2021 |
| Center for Devices Radiological Health | Center for Drug Evaluation BIMO Compliance Program | Center for Drug Evaluation BIMO Compliance Program |
| Medical Device – AI/CAD | Drug | Drug |
| Oncology | Oncology | Oncology |
| 1 Auditor | 1 Auditor | 2 Auditors |
| 5-man days | 5-man days | 8-man days |
| Zero 483 Observations | Zero 483 Observations | Zero 483 Observations |
FDA Inspected — a record of regulatory excellence.