CSL Behring LLC
Form 483 issued September 24, 2021 · Bradley, Illinois
- Inspection
- Sep 13 – Sep 24, 2021
- Investigators
- Claire M. Minden· Debra M. Emerson· Prabhu P. Raju
- Observations
- 9
- Pages
- 9
- FEI number
- 1410248
In short: On September 24, 2021, FDA issued a Form 483 with 9 observations to CSL Behring LLC in Bradley, Illinois (FEI 1410248) after an inspection that ran Sep 13 – Sep 24, 2021. The investigators were Claire M. Minden, Debra M. Emerson and Prabhu P. Raju. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 7 of 9 observations.
Most cited: 21 CFR 211.113 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining air supply and the system…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 04
Corrective actions to equipment maintenance issues…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmCSL Behring LLC history
All 3 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 LLC?
FDA listed 9 observations on this Form 483, mostly about production, facilities & equipment and biologics CGMP. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected CSL Behring LLC?
Claire M. Minden, Debra M. Emerson and Prabhu P. Raju are named on this Form 483, for the inspection of Sep 13 – Sep 24, 2021. Each investigator has a profile showing what they cite most.
When was CSL Behring LLC inspected by FDA?
The inspection ran Sep 13 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.
How do I get the full Form 483 for CSL Behring LLC?
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.