RESHIP.COM
⚠️ High Risk
FEI: 3015006784 • Milton Keynes • UNITED KINGDOM
FEI Number
3015006784
Location
Milton Keynes
Country
UNITED KINGDOMAddress
The Gateway, 68 Tanners Drive, Milton Keynes, , 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2026 | 86NICLENS, CONTACT, FOR READING DISCOMFORT | 237NO PMA | Division of Northeast Imports (DNEI) |
| 2/18/2025 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 2/9/2024 | 86NICLENS, CONTACT, FOR READING DISCOMFORT | 3280FRNMFGREG | Division of Northeast Imports (DNEI) |
| 7/7/2023 | 86HJKLENS, CONTACT, POLYMETHYLMETHACRYLATE, DIAGNOSTIC | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is RESHIP.COM's FDA import refusal history?
RESHIP.COM (FEI: 3015006784) has 4 FDA import refusal record(s) in our database, spanning from 7/7/2023 to 1/21/2026.
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. RESHIP.COM's FEI number is 3015006784.
What types of violations has RESHIP.COM received?
RESHIP.COM 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 RESHIP.COM come from?
All FDA import refusal data for RESHIP.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.