CSL Plasma, Inc.
Form 483 issued February 7, 2025 · Union, South Carolina
- Inspection
- Feb 3 – Feb 7, 2025
- Investigator
- Jared P. Stevens
- Observations
- 1
- Pages
- 3
- FEI number
- 1053087
In short: On February 7, 2025, FDA issued a Form 483 with 1 observation to CSL Plasma, Inc. in Union, South Carolina (FEI 1053087) after an inspection that ran Feb 3 – Feb 7, 2025. The investigator was Jared P. Stevens. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Jared P. Stevens
15 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in South Carolina.
The firmCSL Plasma, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
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 laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected CSL Plasma, Inc.?
Jared P. Stevens is named on this Form 483, for the inspection of Feb 3 – Feb 7, 2025. Each investigator has a profile showing what they cite most.
When was CSL Plasma, Inc. inspected by FDA?
The inspection ran Feb 3 – Feb 7, 2025, and the Form 483 is dated February 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.