BioLife Plasma Services L.P.
Form 483 issued November 22, 2024 · Arlington, Texas
- Inspection
- Nov 19 – Nov 22, 2024
- Investigator
- Michelle Paxon
- Observations
- 1
- Pages
- 3
- FEI number
- 3017393622
In short: On November 22, 2024, FDA issued a Form 483 with 1 observation to BioLife Plasma Services L.P. in Arlington, Texas (FEI 3017393622) after an inspection that ran Nov 19 – Nov 22, 2024. The investigator was Michelle Paxon. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).
At a glance
1 of 1 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 606.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Failure to maintain donor, quality…
This inspection in context
Michelle Paxon
3 documents · 2024–2025
Cites 1271.55(b)(2) (what records must accompany an hct/p after the donor-eligibility determination is complete; and what records must i retain?) more than any other section. Most of their documents are for sites in Texas.
The firmBioLife Plasma Services L.P. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.160(b)
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 1 observation on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.160 (records). The opening words of each observation are shown on this page.
Who inspected BioLife Plasma Services L.P.?
Michelle Paxon is named on this Form 483, for the inspection of Nov 19 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was BioLife Plasma Services L.P. inspected by FDA?
The inspection ran Nov 19 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
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.