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 |
Inspection #1 covered a medical device AI/CAD trial (see our medical device imaging core lab); inspections #2 and #3 covered oncology drug trials.
FDA Inspected — a record of regulatory excellence.
What Our Inspection Record Means for Sponsors
Our inspections were conducted by both the Center for Devices and Radiological Health and the Center for Drug Evaluation's Bioresearch Monitoring (BIMO) Compliance Program, covering medical device, AI/CAD and drug oncology trials. Completing each with zero 483 observations gives sponsors confidence that the imaging data supporting their regulatory submissions was collected, reviewed and documented under controlled, auditable processes.
This record is supported by our Quality Management System, certified by the British Standards Institution (BSI) to ISO 9001 and ISO 13485, alongside ISO 22301, ISO 27001 and ISO 27018 certifications for business continuity, information security and protection of personal data. Together, these standards help ensure your trial's imaging endpoints are inspection-ready from study start-up to database lock.
Imaging Study Records for Inspection Readiness
Inspection readiness is maintained through the study, not assembled only when an inspection is announced. Our imaging workstream preserves the records needed to explain how an endpoint was acquired, assessed and delivered.
From Source Image to Final Endpoint
A traceable review history connects the examination, quality checks, reader assessment, adjudication and final data transfer. Charter versions, acquisition instructions, qualification records and query resolution provide context for those decisions. Sponsor reconciliation confirms that delivered results match the agreed study scope.
Supporting Sponsor Audits and Regulatory Questions
We support review of imaging methods, controlled processes and study records, including explanations of blinding, missing examinations and endpoint derivation. Our prior zero-483 inspection outcomes describe those inspections; they are not FDA endorsement of a product or a guarantee of a future inspection result.