FDA Form 483 Octapharma Plasma Inc, Sparks, NV June 2025
Form 483 issued June 5, 2025 · Sparks, Nevada
- Inspection
- May 30 – Jun 5, 2025
- Observations
- 2
- Pages
- 3
- FEI number
- 5989022
In short: On June 5, 2025, FDA issued a Form 483 with 2 observations to FDA Form 483 Octapharma Plasma Inc, Sparks, NV June 2025 in Sparks, Nevada (FEI 5989022) after an inspection that ran May 30 – Jun 5, 2025. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
2 of 2 observations on this 483 concern biologics cgmp.
Most cited: 21 CFR 640.63 (1×) · 606.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 640.63
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…
This inspection in context
Questions about this 483
What did FDA find at FDA Form 483 Octapharma Plasma Inc, Sparks, NV June 2025?
FDA listed 2 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
When was FDA Form 483 Octapharma Plasma Inc, Sparks, NV June 2025 inspected by FDA?
The inspection ran May 30 – Jun 5, 2025, and the Form 483 is dated June 5, 2025.
How do I get the full Form 483 for FDA Form 483 Octapharma Plasma Inc, Sparks, NV June 2025?
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.