Overview
- 9 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-10-25.
At a glance
Inspections
9
Form 483s
5
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Oct 2019 – 25 Oct 2019 | Human Drugs | Clean | |
| 30 Apr 2018 – 8 May 2018 | Human Drugs | 483 | View 483 → |
| 7 Mar 2016 – 15 Mar 2016 | Human Drugs | 483 | On file |
| 28 Apr 2014 – 6 May 2014 | Human Drugs | 483 | View 483 → |
| 16 Oct 2012 | Not recorded | 483 | On file |
| 11 Feb 2010 | Not recorded | 483 | On file |
| 6 May 2005 | Not recorded | Clean | |
| 3 Oct 2003 | Not recorded | Clean | |
| 6 Dec 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
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
Investigators
FDA investigators tied to this site in the record.
Christopher D Leach2 insp.
MRA DavisM1 insp.
Seneca D Toms1 insp.
Milva E Melendez1 insp.
Jose A Cruz Gonzalez1 insp.
Jose E Melendez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | 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 site report
Get the verbatim findings behind Xellia Pharmaceuticals ApS' 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat