FDA Inspection
XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc. – FDA Inspection, Mar 8, 2012
Record Details
This FDA Inspection record concerns XGen Pharmaceuticals DJB, Inc., with an inspection on March 8, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 8, 2012
- Product Type
- Drugs
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ID · ed8f5a68-6148-47d0-97da-e797fa028ef3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769993
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Complaint Handling Procedure
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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 |
| 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 |
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