FDA Inspection
Xanodyne Pharmaceuticals IncXanodyne Pharmaceuticals Inc – FDA Inspection, Mar 30, 2012
Record Details
This FDA Inspection record concerns Xanodyne Pharmaceuticals Inc, with an inspection on March 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Xanodyne Pharmaceuticals Inc
- Inspection Date
- March 30, 2012
- Product Type
- Drugs
View Company Profile
ID · 72da243d-d69e-44f1-bd09-2645b078b45d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777479
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
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Other FDA inspections of Xanodyne Pharmaceuticals Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Xanodyne Pharmaceuticals Inc
- FDA Inspection 895538 - 2014-09-16
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