Helios Cardio Inc.
FDA inspection history on file, 2026
- 1
- Form 483
Every document, by year
- Form 483
2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2026One Form 483.
Cited most
Across all Helios Cardio observations on file
- 21 CFR 820.50Purchasing controls1
The complete Helios Cardio file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-06 | 483 Form 483 | — | 1 | $99 |
Investigators on these documents
FEI number 3020856782 · most recent document Mar 6, 2026
About Helios Cardio Inc.
How many FDA Form 483s has Helios Cardio Inc. received?
FDA Intel has 1 Form 483 on file for Helios Cardio Inc.; the most recent is dated Mar 6, 2026.
When was Helios Cardio Inc. last inspected by FDA?
The most recent FDA inspection document on file for Helios Cardio Inc. is a Form 483 dated Mar 6, 2026.
What did FDA cite at Helios Cardio Inc.?
The regulations cited most in the observations on file for Helios Cardio Inc. are 21 CFR 820.50 (Purchasing controls), 1 time.