CSL Plasma Inc.
Form 483 issued August 7, 2025
- Inspection
- Aug 4 – Aug 7, 2025
- Investigator
- Conor J. McCarron
- Observations
- 1
- Pages
- 2
- FEI number
- 3012267107
In short: On August 7, 2025, FDA issued a Form 483 with 1 observation to CSL Plasma Inc. (FEI 3012267107) after an inspection that ran Aug 4 – Aug 7, 2025. The investigator was Conor J. McCarron. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.170 (adverse reaction file).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.170 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to maintain records of transfusion reaction reports and complaints, including…
This inspection in context
Conor J. McCarron
3 documents · 2025–2026
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in Colorado.
The firmCSL Plasma Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.170
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSL Plasma Inc.?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.170 (adverse reaction file). The opening words of each observation are shown on this page.
Who inspected CSL Plasma Inc.?
Conor J. McCarron is named on this Form 483, for the inspection of Aug 4 – Aug 7, 2025. Each investigator has a profile showing what they cite most.
When was CSL Plasma Inc. inspected by FDA?
The inspection ran Aug 4 – Aug 7, 2025, and the Form 483 is dated August 7, 2025.
How do I get the full Form 483 for CSL Plasma Inc.?
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.