Company
United StatesHardten, David R., MD, Clinical Investigator, Bloomington, MN – FDA Inspections
Inspection records and compliance data for Hardten, David R., MD, Clinical Investigator in Bloomington, Minnesota. 2 FDA inspections on record, 1 Form 483, last inspected March 09, 2018.
Company Profile
This profile covers Hardten, David R., MD, Clinical Investigator based in Bloomington, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected January 27, 2014. Last inspected March 9, 2018.
Most cited issue areas
- Case history records- inadequate or inadequate1 inspection
- Investigator non-compliance with agreement/plan/regulations1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 9, 2018 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1044543 |
| January 27, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 863042 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Hardten, David R., MD, Clinical Investigator
FEI Number
3003294371
Address
9801 Dupont Ave S, Bloomington, Minnesota 55431, United States
Country
United States
ID: f6cb3cf0-5dc7-4065-b0a9-06c58dd0faa3