CSL Behring GmbH Emil-Von-Behring-Str. 76
Form 483 issued February 18, 2026 · Marburg, Germany
- Inspection
- Feb 9 – Feb 18, 2026
- Investigators
- Burnell M. Henry· Travis S. Bradley
- Observations
- 1
- Pages
- 9
- FEI number
- 3003098680
In short: On February 18, 2026, FDA issued a Form 483 with 1 observation to CSL Behring GmbH Emil-Von-Behring-Str. 76 in Marburg, Germany (FEI 3003098680) after an inspection that ran Feb 9 – Feb 18, 2026. The investigators were Burnell M. Henry and Travis S. Bradley. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Changes to written procedures are not reviewed and approved by…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmCSL Behring GmbH Emil-Von-Behring-Str. 76 history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSL Behring GmbH Emil-Von-Behring-Str. 76?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected CSL Behring GmbH Emil-Von-Behring-Str. 76?
Burnell M. Henry and Travis S. Bradley are named on this Form 483, for the inspection of Feb 9 – Feb 18, 2026. Each investigator has a profile showing what they cite most.
When was CSL Behring GmbH Emil-Von-Behring-Str. 76 inspected by FDA?
The inspection ran Feb 9 – Feb 18, 2026, and the Form 483 is dated February 18, 2026.
How do I get the full Form 483 for CSL Behring GmbH Emil-Von-Behring-Str. 76?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.