CSL Behring GmbH Emil-Von-Behring-Str. 76

Form 483 issued April 30, 2024 · Marburg, Germany

Inspection: Apr 22 – Apr 30, 2024
Investigators: Charles Yuan-Chia Kuo· Richard Ledwidge
Observations: 7
Pages: 6
FEI number: 3003098680

In short: On April 30, 2024, FDA issued a Form 483 with 7 observations to CSL Behring GmbH Emil-Von-Behring-Str. 76 in Marburg, Hesse (FEI 3003098680) after an inspection that ran Apr 22 – Apr 30, 2024. The investigators were Charles Yuan-Chia Kuo and Richard Ledwidge. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).

At a glance

Observations span 4 systems, led by production.

Production2

Quality system2

Facilities & equipment2

Laboratory controls1

Most cited: 21 CFR 211.113 (2×) · 211.192 (2×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.113
Thee Sarug product manufacturing aseptic process is not optimally designed to i e potential…
02
21 CFR 211.22 21 CFR 211.192
Quality oversite is…
03
21 CFR 211.113
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
04
21 CFR 211.42
Your firm’s aseptic processing area for the drug product Fining Line are deficient regarding personnel monitoring…

3 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Charles Yuan-Chia Kuo

2 documents · 2023–2024

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.

The firm

CSL 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 483s

Other sites cited under 211.113

See how FDA wrote the same problem up elsewhere.

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Questions about this 483

What did FDA find at CSL Behring GmbH Emil-Von-Behring-Str. 76?

FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.

Who inspected CSL Behring GmbH Emil-Von-Behring-Str. 76?

Charles Yuan-Chia Kuo and Richard Ledwidge are named on this Form 483, for the inspection of Apr 22 – Apr 30, 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 22 – Apr 30, 2024, and the Form 483 is dated April 30, 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.