Overview
- 5 public-safe observations are available for this inspection.
- 5 structured CFR citations are represented.
- 2 investigators are tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
16 Feb 2018
21 CFR 314.80(c)(2)
Late submission of annual safety reports
Cited by Karen L Kosar, Diane E Bruce
16 Feb 2018
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Karen L Kosar, Diane E Bruce
16 Feb 2018
21 CFR 329.100(c)(1)
Failure to submit report in approved electronic format
Cited by Karen L Kosar, Diane E Bruce
Inspected site
XPXGen Pharmaceuticals DJB, Inc.Horseheads, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(c)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.80(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 329.100(c)(1) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 5 observations
Every observation in full, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere