Swann Morton, Ltd.
⚠️ Moderate Risk
FEI: 3002808293 • Sheffield, SHF • UNITED KINGDOM
FEI Number
3002808293
Location
Sheffield, SHF
Country
UNITED KINGDOMAddress
Owlerton Green, , Sheffield, SHF, 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
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/28/2023 | 79GDXSCALPEL, ONE-PIECE | Division of Southeast Imports (DSEI) | |
| 8/7/2023 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | Division of Southeast Imports (DSEI) | |
| 7/7/2022 | 79GESBLADE, SCALPEL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Swann Morton, Ltd.'s FDA import refusal history?
Swann Morton, Ltd. (FEI: 3002808293) has 3 FDA import refusal record(s) in our database, spanning from 7/7/2022 to 12/28/2023.
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. Swann Morton, Ltd.'s FEI number is 3002808293.
What types of violations has Swann Morton, Ltd. received?
Swann Morton, Ltd. 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 Swann Morton, Ltd. come from?
All FDA import refusal data for Swann Morton, Ltd. 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.