BioLife Plasma Services LP
Form 483 · Bakersfield, California
- Investigator
- Michelle D. Gutierrez
- Observations
- 1
- Pages
- 2
- FEI number
- 3026578734
In short: FDA issued a Form 483 with 1 observation to BioLife Plasma Services LP in Bakersfield, California (FEI 3026578734). The investigator was Michelle D. Gutierrez. The most-cited regulation is 21 CFR 630.40 (requirements for notifying deferred donors).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 630.40
The firm does not always provide all screening and additional/supplemental/confirmatory test results obtained from testing for…
This inspection in context
Michelle D. Gutierrez
1 document
Cites 630.40 (requirements for notifying deferred donors) more than any other section. Most of their documents are for sites in California.
The firmBioLife Plasma Services LP history
The site's inspection history, in date order.
Similar 483sMore form 483s
Browse other documents of this type.
Questions about this 483
What did FDA find at BioLife Plasma Services LP?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 630.40 (requirements for notifying deferred donors). The opening words of each observation are shown on this page.
Who inspected BioLife Plasma Services LP?
Michelle D. Gutierrez is named on this Form 483. Each investigator has a profile showing what they cite most.
How do I get the full Form 483 for BioLife Plasma Services LP?
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.