FDA Inspection 954335 — XGen Pharmaceuticals DJB, Inc.
The FDA completed an inspection of XGen Pharmaceuticals DJB, Inc. on Dec 23, 2015 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 23, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Horseheads, NY (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 6729 | 21 CFR 314.80(b) | Failure to submit follow-up information to FDA |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |
| 6841 | 21 CFR 314.80(f)(1) | Incomplete patient information on ICSR |