Skypax
⚠️ Moderate Risk
FEI: 3009297884 • Twickenhamtwickenham • UNITED KINGDOM
FEI Number
3009297884
Location
Twickenhamtwickenham
Country
UNITED KINGDOMAddress
1a Rugby Road Big Yellow Storagebig, , Twickenhamtwickenham, , United Kingdom
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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 |
|---|---|---|---|
| 10/20/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 10/20/2022 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/17/2014 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Skypax's FDA import refusal history?
Skypax (FEI: 3009297884) has 3 FDA import refusal record(s) in our database, spanning from 7/17/2014 to 10/20/2022.
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. Skypax's FEI number is 3009297884.
What types of violations has Skypax received?
Skypax has been cited for 2 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 Skypax come from?
All FDA import refusal data for Skypax 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.