FDA Inspection
XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc. – FDA Inspection, Feb 16, 2018
Record Details
This FDA Inspection record concerns XGen Pharmaceuticals DJB, Inc., with an inspection on February 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Diane E. Bruce (Issuing Officer)
- Karen L. Kosar (FDA Associated Person)
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ID · 68e925f6-2144-4752-b80c-f880b2ae982a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041478
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 329.100(c)(1)Failure to submit report in approved electronic format
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(j)Failure to maintain records
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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 |
| 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 |
| 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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