FDA Inspection
Vivus, Inc.Vivus, Inc. – FDA Inspection, Apr 26, 2013
Record Details
This FDA Inspection record concerns Vivus, Inc., with an inspection on April 26, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Vivus, Inc.
- Inspection Date
- April 26, 2013
- Product Type
- Drugs
View Company Profile
ID · b00ba888-0fb9-425f-8712-2fa7f2ccb340
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829906
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Vivus, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2023 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 28, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 31, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 30, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Vivus, Inc.
- FDA Inspection 1218963 - 2023-09-08
- FDA Inspection 1081231 - 2018-11-28
- FDA Inspection 865709 - 2014-01-31
- FDA Inspection 756318 - 2011-11-30
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