CSL Plasma Inc 3501 Cedar St Space 7
Form 483 issued February 6, 2026 · Philadelphia, Pennsylvania
- Inspection
- Feb 3 – Feb 6, 2026
- Investigator
- Emily A. Walters
- Observations
- 2
- Pages
- 3
- FEI number
- 3022099864
In short: On February 6, 2026, FDA issued a Form 483 with 2 observations to CSL Plasma Inc 3501 Cedar St Space 7 in Philadelphia, Pennsylvania (FEI 3022099864) after an inspection that ran Feb 3 – Feb 6, 2026. The investigator was Emily A. Walters. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 640.64 (collection of blood for Source Plasma).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 640.64(e) (1×) · 606.171 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The phlebotomy site is not prepared by a method that gives maximum assurance of a…
- 02
Failure to submit a biological product deviation report within 45 days from the date you acquired…
This inspection in context
Emily A. Walters
1 document · 2026
Cites 606.171 (reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCSL Plasma Inc 3501 Cedar St Space 7 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 640.64(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSL Plasma Inc 3501 Cedar St Space 7?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 640.64 (collection of blood for Source Plasma). The opening words of each observation are shown on this page.
Who inspected CSL Plasma Inc 3501 Cedar St Space 7?
Emily A. Walters is named on this Form 483, for the inspection of Feb 3 – Feb 6, 2026. Each investigator has a profile showing what they cite most.
When was CSL Plasma Inc 3501 Cedar St Space 7 inspected by FDA?
The inspection ran Feb 3 – Feb 6, 2026, and the Form 483 is dated February 6, 2026.
How do I get the full Form 483 for CSL Plasma Inc 3501 Cedar St Space 7?
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.