FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025
Form 483 issued February 27, 2025 · Denver, Colorado
- Inspection
- Feb 25 – Feb 27, 2025
- Investigators
- Celeta S. Coves· Marc A. Jackson
- Observations
- 1
- Pages
- 3
- FEI number
- 3015045325
In short: On February 27, 2025, FDA issued a Form 483 with 1 observation to FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025 in Denver, Colorado (FEI 3015045325) after an inspection that ran Feb 25 – Feb 27, 2025. The investigators were Celeta S. Coves and Marc A. Jackson. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Celeta S. Coves
1 document · 2025
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Colorado.
The firmFDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025?
Celeta S. Coves and Marc A. Jackson are named on this Form 483, for the inspection of Feb 25 – Feb 27, 2025. Each investigator has a profile showing what they cite most.
When was FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 2025 inspected by FDA?
The inspection ran Feb 25 – Feb 27, 2025, and the Form 483 is dated February 27, 2025.
How do I get the full Form 483 for FDA Form 483 SeaStar Medical Inc., Denver, CO Feb 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.