BOOHOO.COM
⚠️ High Risk
FEI: 3015910338 • Manchester • UNITED KINGDOM
FEI Number
3015910338
Location
Manchester
Country
UNITED KINGDOMAddress
49-51 Dale Street, , Manchester, , United Kingdom
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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/11/2022 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 10/5/2022 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 7/15/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/17/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/17/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 5/18/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 10/21/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 8/18/2021 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 8/18/2021 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 8/9/2021 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 8/4/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/4/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/4/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 7/23/2021 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Southeast Imports (DSEI) | |
| 6/24/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/24/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/14/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BOOHOO.COM's FDA import refusal history?
BOOHOO.COM (FEI: 3015910338) has 17 FDA import refusal record(s) in our database, spanning from 6/14/2021 to 10/11/2022.
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. BOOHOO.COM's FEI number is 3015910338.
What types of violations has BOOHOO.COM received?
BOOHOO.COM 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 BOOHOO.COM come from?
All FDA import refusal data for BOOHOO.COM 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.