FDA Inspection
XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc. – FDA Inspection, Jun 22, 2018
Record Details
This FDA Inspection record concerns XGen Pharmaceuticals DJB, Inc., with an inspection on June 22, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Jay T. Wong (Issuing Officer)
View Company Profile
ID · b06c3904-011f-45d6-8c89-27ce5387c493
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056541
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.150Written distribution 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 |
| 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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