CSL Behring GmbH Emil-Von-Behring-Str. 76
Form 483 issued March 4, 2022 · Marburg, Germany
- Inspection
- Mar 4, 2022
- Investigators
- Debra M. Emerson· Prabhu P. Raju
- Observations
- 6
- Pages
- 5
- FEI number
- 3003098680
In short: On March 4, 2022, FDA issued a Form 483 with 6 observations to CSL Behring GmbH Emil-Von-Behring-Str. 76 in Marburg, Hesse (FEI 3003098680) after an inspection that ran Mar 4, 2022. The investigators were Debra M. Emerson and Prabhu P. Raju. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies the failure of a batch or any of its…
- 02
The following Product Technical Complaint (PTC) records did not include sufficient rationale for why investigations of…
- 03
Buildings used in the manufacture, processing, packing, or holding of U.S. licensed drug products were not…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to…
This inspection in context
Debra M. Emerson
27 documents · 2008–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.192
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 6 observations on this Form 483, mostly about quality system, facilities & equipment and 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?
Debra M. Emerson and Prabhu P. Raju are named on this Form 483, for the inspection of Mar 4, 2022. 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 Mar 4, 2022, and the Form 483 is dated March 4, 2022.
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.