FDA Inspection
Hardten, David R., MD, Clinical InvestigatorHardten, David R., MD, Clinical Investigator – FDA Inspection, Mar 9, 2018
Record Details
This FDA Inspection record concerns Hardten, David R., MD, Clinical Investigator, with an inspection on March 9, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3affa3f-6a24-4d14-8aef-36f6f497962c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1044543
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.110(b)Investigator non-compliance with agreement/plan/regulations
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Other FDA inspections of Hardten, David R., MD, Clinical Investigator
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 27, 2014 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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