Company
United StatesMark A Klaassen, M.D., Elkhart, IN – FDA Inspections
Inspection records and compliance data for Mark A Klaassen, M.D. in Elkhart, Indiana. 2 FDA inspections on record, last inspected September 18, 2012.
Company Profile
This profile covers Mark A Klaassen, M.D. based in Elkhart, Indiana, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected September 28, 2010. Last inspected September 18, 2012.
Most cited issue areas
- Investigator non-compliance with agreement/plan/regulations2 inspections
- Conduct: changes not obscuring original entries1 inspection
- Investigator adverse effect records inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 18, 2012 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 799601 |
| September 28, 2010 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 683586 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Mark A Klaassen, M.D.
FEI Number
3007900399
Address
Orthopedic Sports Med.Ctr.of Northern In, 2310 California Rd., Suite A, Elkhart, Indiana 46514, United States
Country
United States
ID: 52d5d7fe-48aa-4ed1-87e7-9908fd594eab