FDA Inspection 769993 — XGen Pharmaceuticals DJB, Inc.
The FDA completed an inspection of XGen Pharmaceuticals DJB, Inc. on March 8, 2012 in Horseheads, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 8, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Horseheads, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |