FDA Inspection
Hardten, David R., MD, Clinical InvestigatorHardten, David R., MD, Clinical Investigator – FDA Inspection, Jan 27, 2014
Record Details
This FDA Inspection record concerns Hardten, David R., MD, Clinical Investigator, with an inspection on January 27, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 27, 2014
- Product Type
- Drugs
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ID · 2c866e3e-5c4a-4c23-ae98-e24552effe3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 863042
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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Other FDA inspections of Hardten, David R., MD, Clinical Investigator
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2018 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
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