HELENA S.R.L.
⚠️ Moderate Risk
FEI: 3012682739 • Ica, Ica • PERU
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2017 | 34GFT99CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS AND FRUIT, N.E.C. | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HELENA S.R.L.'s FDA import refusal history?
HELENA S.R.L. (FEI: 3012682739) has 1 FDA import refusal record(s) in our database, spanning from 3/15/2017 to 3/15/2017.
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. HELENA S.R.L.'s FEI number is 3012682739.
What types of violations has HELENA S.R.L. received?
HELENA S.R.L. 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 HELENA S.R.L. come from?
All FDA import refusal data for HELENA S.R.L. 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.