Team Ioca De Honduras Sa De Cv
⚠️ Moderate Risk
FEI: 3011823792 • Tegucigalpa, Francisco Morazan • HONDURAS
FEI Number
3011823792
Location
Tegucigalpa, Francisco Morazan
Country
HONDURASAddress
Torre Consortium 1 Blvd Morazan Col La, , Tegucigalpa, Francisco Morazan, Honduras
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 11/24/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 11/24/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 11/24/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 10/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 10/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) | |
| 10/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Team Ioca De Honduras Sa De Cv's FDA import refusal history?
Team Ioca De Honduras Sa De Cv (FEI: 3011823792) has 7 FDA import refusal record(s) in our database, spanning from 10/29/2015 to 11/24/2015.
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. Team Ioca De Honduras Sa De Cv's FEI number is 3011823792.
What types of violations has Team Ioca De Honduras Sa De Cv received?
Team Ioca De Honduras Sa De Cv has been cited for 4 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 Team Ioca De Honduras Sa De Cv come from?
All FDA import refusal data for Team Ioca De Honduras Sa De Cv 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.