BioLife Plasma Services L.P.
Form 483 issued February 20, 2026 · Kokomo, Indiana
- Inspection
- Feb 10 – Feb 20, 2026
- Investigator
- Lesley Mae P. Lutao
- Observations
- 3
- Pages
- 5
- FEI number
- 3004582762
In short: On February 20, 2026, FDA issued a Form 483 with 3 observations to BioLife Plasma Services L.P. in Kokomo, Indiana (FEI 3004582762) after an inspection that ran Feb 10 – Feb 20, 2026. The investigator was Lesley Mae P. Lutao. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.171 (reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services).
At a glance
3 of 3 observations on this 483 concern 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 perform a thorough investigation…
- 02
Records are not concurrently maintained with the performance of each significant step in the collection of…
- 03
Failure to submit a supplement at least 30 days prior to distributing product…
This inspection in context
Lesley Mae P. Lutao
4 documents · 2024–2026
Cites 1271.220(c) (processing and process controls) more than any other section. Most of their documents are for sites in Indiana.
The firmBioLife Plasma Services L.P. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 606.171
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 3 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.171 (reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services). The opening words of each observation are shown on this page.
Who inspected BioLife Plasma Services L.P.?
Lesley Mae P. Lutao is named on this Form 483, for the inspection of Feb 10 – Feb 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 Feb 10 – Feb 20, 2026, and the Form 483 is dated February 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.