Helios
⚠️ High Risk
FEI: 3003688360 • Valladolid • SPAIN
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2008 | 21GCI09OLIVES (PIT FRUIT) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 21GCI09OLIVES (PIT FRUIT) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 25ECI06CUCUMBERS AND ONIONS (MIXED VEGETABLES) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 24TCI04BEET TOPS (LEAF & STEM VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 24FCI07PEPPER, SWEET (FRUIT USED AS VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 25ECI06CUCUMBERS AND ONIONS (MIXED VEGETABLES) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 25ECI06CUCUMBERS AND ONIONS (MIXED VEGETABLES) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/3/2008 | 25JCI25ONION BULB (YELLOW, WHITE, RED, ETC.) (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 25JCI01CARROT (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 24TCI44CELERIAC (ROOT CELERY) (LEAF & STEM VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 24ECI99BEAN AND PEA SPROUTS, N.E.C. (VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 24ECI99BEAN AND PEA SPROUTS, N.E.C. (VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 24ECI99BEAN AND PEA SPROUTS, N.E.C. (VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 24ECI99BEAN AND PEA SPROUTS, N.E.C. (VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 4/1/2008 | 24ECI99BEAN AND PEA SPROUTS, N.E.C. (VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 3/19/2008 | 24ACI51PEAS | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 3/19/2008 | 24ACI05FAVA BEAN | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 3/19/2008 | 25ECI02CARROTS AND PEAS (SWEET) (MIXED VEGETABLES) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 3/19/2008 | 25JCI01CARROT (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 24TCI99LEAF & STEM VEGETABLES, N.E.C. | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 24ECI14STRINGBEANS, BEAN AND PEA SPROUTS | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 24TCI26SWISS CHARD (LEAF & STEM VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 25JCI21GARLIC BULB (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 25JCI03LEEK (A TYPE OF ONION) (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 24TCI25SPINACH (LEAF & STEM VEGETABLE) | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 24TCI99LEAF & STEM VEGETABLES, N.E.C. | 83NO PROCESS | Chicago District Office (CHI-DO) |
| 2/26/2008 | 25ECI99MIXED VEGETABLES, N.E.C. | 83NO PROCESS | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Helios's FDA import refusal history?
Helios (FEI: 3003688360) has 28 FDA import refusal record(s) in our database, spanning from 2/26/2008 to 4/3/2008.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Helios's FEI number is 3003688360.
What types of violations has Helios received?
Helios has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Helios come from?
All FDA import refusal data for Helios is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.