FDA Inspection
XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc. – FDA Inspection, Jun 14, 2024
Record Details
This FDA Inspection record concerns XGen Pharmaceuticals DJB, Inc., with an inspection on June 14, 2024, issued by the Center for Drug Evaluation and Research.
- Inspection Date
- June 14, 2024
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ID · c5cd5149-0c5b-4980-8eb0-631d34b881ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1233326
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
FDA Citations
4- 21 CFR 314.80(f)(1)Incomplete patient information on ICSR
- 21 CFR 314.80(g)(1)Failure to submit electronic format safety report
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(f)(4)Incomplete initial reporter information on ICSR
Full citation text and observation details available on the Dashboard.
Other FDA inspections of XGen Pharmaceuticals DJB, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 22, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 16, 2018 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| December 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 8, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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