FDA Inspection
XGen Pharmaceuticals DJB, Inc.XGen Pharmaceuticals DJB, Inc. – FDA Inspection, Dec 23, 2015
Record Details
This FDA Inspection record concerns XGen Pharmaceuticals DJB, Inc., with an inspection on December 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 23, 2015
- Product Type
- Drugs
View Company Profile
ID · fc163fab-7c62-45f1-a5d6-85fe62e38051
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 954335
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 314.80(c)Failure by applicant to report ADE
- 21 CFR 314.80(f)(1)Incomplete patient information on ICSR
- 21 CFR 314.80(b)Failure to submit follow-up information to FDA
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
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 |
| March 8, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for XGen Pharmaceuticals DJB, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.