FDA Inspection
Paul Sorajja, M.D., Clinical InvestigatorPaul Sorajja, M.D., Clinical Investigator – FDA Inspection, Mar 22, 2019
Record Details
This FDA Inspection record concerns Paul Sorajja, M.D., Clinical Investigator, with an inspection on March 22, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4889b481-2be8-47f4-a99b-c4590cffcadc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083532
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
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Other FDA inspections of Paul Sorajja, M.D., Clinical Investigator
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 2, 2025 | Not classified | Minneapolis District Office | |
| August 25, 2023 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Paul Sorajja, M.D., Clinical Investigator
- FDA Inspection 1269127 - 2025-05-02
- FDA Inspection 1215907 - 2023-08-25
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