Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-09-29.
At a glance
Inspections
5
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Sep 2023 – 29 Sep 2023 | Human Drugs | 483 | View 483 → |
| 28 Nov 2022 – 15 Dec 2022 | Human Drugs | 483 | On file |
| 24 Jan 2022 – 7 Feb 2022 | Human Drugs | 483 | View 483 → |
| 27 Jan 2020 – 31 Jan 2020 | Human Drugs | 483 | View 483 → |
| 11 Oct 2016 – 13 Oct 2016 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Sep 2023
21 CFR 211.113(b)
Validation lacking for sterile drug products
Cited by Nicholas J Presto, Alan M Barker
29 Sep 2023
21 CFR 211.192
Written record of investigation incomplete
Cited by Nicholas J Presto, Alan M Barker
7 Feb 2022
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Andrew J Barrowcliff, Lisa R Hilliard
31 Jan 2020
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Lauren N Howard, Wendy G Tan, Cassandra L Abellard
31 Jan 2020
21 CFR 211.100(b)
SOPs not followed / documented
Cited by Lauren N Howard, Wendy G Tan, Cassandra L Abellard
Investigators
FDA investigators tied to this site in the record.
Lisa R Hilliard2 insp.
Lauren N Howard2 insp.
Nicholas J Presto1 insp.
Alan M Barker1 insp.
Vaishali J Patel1 insp.
Nibin Varghese1 insp.
Andrew J Barrowcliff1 insp.
Wendy G Tan1 insp.
Cassandra L Abellard1 insp.
Lindsey M Schwierjohann1 insp.
Nicholas L Paulin1 insp.
Lauren N Smith1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 2x |
| 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 211.22(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Xellia Pharmaceuticals USA LLC's 4 Form 483s
Source PDFs 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