FDA Inspection 1233326 — XGen Pharmaceuticals DJB, Inc.
The FDA completed an inspection of XGen Pharmaceuticals DJB, Inc. on Jun 14, 2024 in Horseheads, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Horseheads, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 18028 | 21 CFR 314.80(f)(4) | Incomplete initial reporter information on ICSR |
| 18033 | 21 CFR 314.80(g)(1) | Failure to submit electronic format safety report |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6841 | 21 CFR 314.80(f)(1) | Incomplete patient information on ICSR |