Company
United StatesOlsen Medical, Louisville, KY – FDA Inspections
Inspection records and compliance data for Olsen Medical in Louisville, Kentucky. 3 FDA inspections on record, last inspected August 25, 2015.
Company Profile
This profile covers Olsen Medical based in Louisville, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 3
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected March 9, 2010. Last inspected August 25, 2015.
Most cited issue areas
- Analysis of data sources1 inspection
- Appropriateness1 inspection
- CAPA verification/validation of corrective/preventive action1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 25, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 942880 |
| April 17, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 831331 |
| March 9, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 648580 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Olsen Medical
FEI Number
3000719969
Address
3230 Commerce Center Pl, Louisville, Kentucky 40211, United States
Country
United States
ID: e44ee998-20ef-446d-95a2-c113f2678d40