CSL Behring LLC
Form 483 issued May 23, 2019 · Bradley, Illinois
- Inspection
- May 13 – May 23, 2019
- Investigators
- Mihaly S. Ligmond· Randall L. Morris· Richard T. Riggie
- Observations
- 7
- Pages
- 4
- FEI number
- 1410248
In short: On May 23, 2019, FDA issued a Form 483 with 7 observations to CSL Behring LLC in Bradley, Illinois (FEI 1410248) after an inspection that ran May 13 – May 23, 2019. The investigators were Mihaly S. Ligmond, Randall L. Morris and Richard T. Riggie. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 7 of 7 observations.
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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Aseptic processing areas are deficient regarding the system for…
- 04
Time limits are not established when appropriate for the completion of each production phase to assure…
This inspection in context
Mihaly S. Ligmond
20 documents · 2006–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
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 7 observations on this Form 483, mostly about 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 LLC?
Mihaly S. Ligmond, Randall L. Morris and Richard T. Riggie are named on this Form 483, for the inspection of May 13 – May 23, 2019. Each investigator has a profile showing what they cite most.
When was CSL Behring LLC inspected by FDA?
The inspection ran May 13 – May 23, 2019, and the Form 483 is dated May 23, 2019.
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.