FDA Inspection
XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc. – FDA Inspection, Aug 22, 2019
Record Details
This FDA Inspection record concerns XGen Pharmaceuticals DJB, Inc., with an inspection on August 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d6b0670c-9dc4-4480-9916-340dd0ac3c7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1100288
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 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 XGen Pharmaceuticals DJB, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2024 | VAI | Center for Drug Evaluation and Research | Postmarket Surv. and Epidemiology |
| 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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