Quality
FDA Audited
Intrinsic Imaging has successfully completed three FDA inspections across medical device and drug clinical trials — each closing with zero 483 observations.
| 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.