FDA Inspection 1041478 — XGen Pharmaceuticals DJB, Inc.
The FDA completed an inspection of XGen Pharmaceuticals DJB, Inc. on February 16, 2018 in Horseheads, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Horseheads, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 21255 | 21 CFR 329.100(c)(1) | Failure to submit report in approved electronic format |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6832 | 21 CFR 314.80(c)(2) | Late submission of annual safety reports |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |