FDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025
Form 483 issued February 26, 2025 · Minneapolis, Minnesota
- Inspection
- Feb 20 – Feb 26, 2025
- Investigator
- Kellie L. Thommes
- Observations
- 1
- Pages
- 2
In short: On February 26, 2025, FDA issued a Form 483 with 1 observation to FDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025 in Minneapolis, Minnesota after an inspection that ran Feb 20 – Feb 26, 2025. The investigator was Kellie L. Thommes. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the collection of blood and blood components is not standardized and calibrated on…
This inspection in context
Kellie L. Thommes
4 documents · 2018–2025
Cites 50.23 (exception from general requirements) more than any other section. Most of their documents are for sites in Minnesota.
The firmFDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025?
FDA listed 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025?
Kellie L. Thommes is named on this Form 483, for the inspection of Feb 20 – Feb 26, 2025. Each investigator has a profile showing what they cite most.
When was FDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025 inspected by FDA?
The inspection ran Feb 20 – Feb 26, 2025, and the Form 483 is dated February 26, 2025.
How do I get the full Form 483 for FDA Form 483 CSL Plasma Inc, Minneapolis, MN Feb 2025?
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.