BioLife Plasma Services L.P.
Form 483 issued March 20, 2026
- Inspection
- Mar 10 – Mar 20, 2026
- Investigator
- Shelley H. Beausoleil
- Observations
- 5
- Pages
- 7
- FEI number
- 3023831018
In short: On March 20, 2026, FDA issued a Form 483 with 5 observations to BioLife Plasma Services L.P. (FEI 3023831018) after an inspection that ran Mar 10 – Mar 20, 2026. The investigator was Shelley H. Beausoleil. Most observations concern biologics CGMP.
At a glance
Observations span 1 system, led by biologics cgmp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to determine the eligibility of a donor of blood or…
- 02
The standard operating procedure fails to include written descriptions of methods for performing donor qualifying tests…
- 0321 CFR 630.5
The responsible physician improperly delegated activities related to the collection of…
- 0421 CFR 630.30
Failure to prevent the release of unsuitable blood and blood…
This inspection in context
Shelley H. Beausoleil
3 documents · 2025–2026
Cites 1271.75 (how do i screen a donor?) more than any other section. Most of their documents are for sites in California.
The firmBioLife Plasma Services L.P. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 630.10
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BioLife Plasma Services L.P.?
FDA listed 5 observations on this Form 483, mostly about biologics CGMP. The opening words of each observation are shown on this page.
Who inspected BioLife Plasma Services L.P.?
Shelley H. Beausoleil is named on this Form 483, for the inspection of Mar 10 – Mar 20, 2026. Each investigator has a profile showing what they cite most.
When was BioLife Plasma Services L.P. inspected by FDA?
The inspection ran Mar 10 – Mar 20, 2026, and the Form 483 is dated March 20, 2026.
How do I get the full Form 483 for BioLife Plasma Services L.P.?
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.