Robotis SA
⚠️ Moderate Risk
FEI: 3004253041 • Areti, Elias • GREECE
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
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.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
PESTICIDE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2014 | 24FHI08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 10/23/2014 | 24FHI08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 10/23/2014 | 24FHI08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 2/15/2004 | 24FYI08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE) | 238UNSAFE ADD | New York District Office (NYK-DO) |
| 5/8/2003 | 24FHI07PEPPER, SWEET (FRUIT USED AS VEGETABLE) | 241PESTICIDE | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Robotis SA's FDA import refusal history?
Robotis SA (FEI: 3004253041) has 5 FDA import refusal record(s) in our database, spanning from 5/8/2003 to 10/23/2014.
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. Robotis SA's FEI number is 3004253041.
What types of violations has Robotis SA received?
Robotis SA has been cited for 3 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 Robotis SA come from?
All FDA import refusal data for Robotis SA 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.