Helios Cardio Inc.
Form 483 issued March 6, 2026
- Inspection
- Mar 3 – Mar 6, 2026
- Investigator
- James P. Finn
- Observations
- 1
- Pages
- 3
- FEI number
- 3020856782
In short: On March 6, 2026, FDA issued a Form 483 with 1 observation to Helios Cardio Inc. (FEI 3020856782) after an inspection that ran Mar 3 – Mar 6, 2026. The investigator was James P. Finn. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Outsourced processes that affect product conformity to requirements were not…
This inspection in context
James P. Finn
10 documents · 2019–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmHelios Cardio Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Helios Cardio Inc.?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Helios Cardio Inc.?
James P. Finn is named on this Form 483, for the inspection of Mar 3 – Mar 6, 2026. Each investigator has a profile showing what they cite most.
When was Helios Cardio Inc. inspected by FDA?
The inspection ran Mar 3 – Mar 6, 2026, and the Form 483 is dated March 6, 2026.
How do I get the full Form 483 for Helios Cardio Inc.?
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.