Overview
- 14 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-18.
At a glance
Inspections
14
Form 483s
12
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 18 Feb 2026 | Biologics | 483 | View 483 → |
| 22 Apr 2024 – 30 Apr 2024 | Human Drugs | 483 | On file |
| 15 Apr 2024 – 18 Apr 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Feb 2022 – 4 Mar 2022 | Biologics | 483 | On file |
| 30 Apr 2018 – 17 May 2018 | Biologics | 483 | On file |
| 4 May 2016 – 17 May 2016 | Biologics | 483 | On file |
| 28 May 2015 – 5 Jun 2015 | Biologics | 483 | On file |
| 23 May 2014 – 5 Jun 2014 | Biologics | 483 | On file |
| 27 Jan 2012 | Not recorded | 483 | On file |
| 18 Mar 2010 | Not recorded | 483 | On file |
| 3 Jun 2008 | Not recorded | 483 | On file |
| 3 Apr 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Feb 2026
21 CFR 211.100(a)
Changes to Procedures Not Reviewed, Approved
Cited by Travis S Bradley, Burnell M Henry
18 Feb 2026
21 CFR 211.198(a)
Procedures to be written and followed
Cited by Travis S Bradley, Burnell M Henry
18 Feb 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Travis S Bradley, Burnell M Henry
18 Feb 2026
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Travis S Bradley, Burnell M Henry
18 Feb 2026
21 CFR 600.14(a)(1)
Who must report - manufacturer
Cited by Travis S Bradley, Burnell M Henry
Investigators
FDA investigators tied to this site in the record.
Prabhu P Raju3 insp.
Debra M Emerson2 insp.
Travis S Bradley1 insp.
Burnell M Henry1 insp.
Richard Ledwidge1 insp.
Charles Y Kuo1 insp.
Joshua J Silvestri1 insp.
Arie Menachem1 insp.
Alexey Khrenov1 insp.
Susan M Jackson1 insp.
Donald B Ertel1 insp.
Kevin P Foley1 insp.
Simone E Pitts1 insp.
Cynthia Jim1 insp.
Christian Lynch1 insp.
Paula A Trost1 insp.
Omotunde O Osunsanmi1 insp.
Helen B Ricalde1 insp.
Marion Michaelis1 insp.
Joseph D Doleski1 insp.
Jacqueline M Diaz Albert1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 600.14(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CSL Behring GmbH's 12 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