CSL Behring GmbH Emil-Von-Behring-Str. 76
Form 483 issued April 18, 2024 · Marburg, Germany
- Inspection
- Apr 15 – Apr 18, 2024
- Investigator
- Joshua J. Silvestri
- Observations
- 1
- Pages
- 2
- FEI number
- 3003098680
In short: On April 18, 2024, FDA issued a Form 483 with 1 observation to CSL Behring GmbH Emil-Von-Behring-Str. 76 in Marburg, Hassia (FEI 3003098680) after an inspection that ran Apr 15 – Apr 18, 2024. The investigator was Joshua J. Silvestri. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
This inspection in context
Joshua J. Silvestri
8 documents · 2019–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
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 820.100
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 cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected CSL Behring GmbH Emil-Von-Behring-Str. 76?
Joshua J. Silvestri is named on this Form 483, for the inspection of Apr 15 – Apr 18, 2024. 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 Apr 15 – Apr 18, 2024, and the Form 483 is dated April 18, 2024.
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.