CSL Behring GmbH Emil-Von-Behring-Str. 76
Form 483 issued May 17, 2018 · Marburg, Germany
- Inspection
- Apr 30 – May 17, 2018
- Investigators
- Alexey Khrenov· Arie C. Menachem· Prabhu P. Raju
- Observations
- 13
- Pages
- 14
- FEI number
- 3003098680
In short: On May 17, 2018, FDA issued a Form 483 with 13 observations to CSL Behring GmbH Emil-Von-Behring-Str. 76 in Marburg, Hesse (FEI 3003098680) after an inspection that ran Apr 30 – May 17, 2018. The investigators were Alexey Khrenov, Arie C. Menachem and Prabhu P. Raju. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to initiate, thoroughly review, and follow-up on investigations into unexplained discrepancies for…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 03
Written production and process control procedures are not documented at…
- 04
The stability program is…
This inspection in context
Alexey Khrenov
1 document · 2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Germany.
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 211.113
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 13 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected CSL Behring GmbH Emil-Von-Behring-Str. 76?
Alexey Khrenov, Arie C. Menachem and Prabhu P. Raju are named on this Form 483, for the inspection of Apr 30 – May 17, 2018. 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 30 – May 17, 2018, and the Form 483 is dated May 17, 2018.
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.