Company
United StatesXanodyne Pharmaceuticals Inc, Newport, KY – FDA Inspections
Inspection records and compliance data for Xanodyne Pharmaceuticals Inc in Newport, Kentucky. 2 FDA inspections on record, last inspected September 16, 2014.
Company Profile
This profile covers Xanodyne Pharmaceuticals Inc based in Newport, Kentucky, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 30, 2012. Last inspected September 16, 2014.
Most cited issue areas
- Failure to develop written procedures1 inspection
- Failure to report non-alert ADEs1 inspection
- Failure to review ADE information1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 16, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 895538 |
| March 30, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 777479 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Xanodyne Pharmaceuticals Inc
FEI Number
3003398650
Address
1 Riverfront Pl, Newport, Kentucky 41071, United States
Country
United States
ID: b01a5f80-e25f-4ece-a74e-b88cc295aa02