Overview
- 4 public-safe observations are available for this inspection.
- 4 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.
6 May 2014
21 CFR 211.67(b)
Written procedures fail to include
Cited by Christopher D Leach, Milva E Melendez
6 May 2014
21 CFR 211.68(a)
Calibration/Inspection/Checking not done
Cited by Christopher D Leach, Milva E Melendez
6 May 2014
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Christopher D Leach, Milva E Melendez
6 May 2014
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Christopher D Leach, Milva E Melendez
Inspected site
XPXellia Pharmaceuticals ApSCopenhagen S, Denmark
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(a) | Cited across public-safe Form 483 observations | 1x |
Full 483 report
Get the verbatim text of all 4 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