SMITHS MEDICAL INTERNATIONAL LTD.
⚠️ Moderate Risk
FEI: 3002807908 • Hythe, Kent • UNITED KINGDOM
FEI Number
3002807908
Location
Hythe, Kent
Country
UNITED KINGDOMAddress
Boundary Road, , Hythe, Kent, 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
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).
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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 |
|---|---|---|---|
| 5/8/2018 | 80FPKTUBING, FLUID DELIVERY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/13/2011 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/13/2011 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/11/2011 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
| 5/15/2007 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/16/2006 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/6/2006 | 37YFT01GIFT PACKS OF ASSORTED FOODS, READY-TO-EAT | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 7/19/2005 | 79FZXGUIDE, SURGICAL, INSTRUMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/14/2005 | 87MRYAPPLIANCES AND ACCESSORIES, FIXATION, BONE, ABSORBABLE SINGLE/MULTIPLE COMPONENT | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is SMITHS MEDICAL INTERNATIONAL LTD.'s FDA import refusal history?
SMITHS MEDICAL INTERNATIONAL LTD. (FEI: 3002807908) has 9 FDA import refusal record(s) in our database, spanning from 1/14/2005 to 5/8/2018.
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. SMITHS MEDICAL INTERNATIONAL LTD.'s FEI number is 3002807908.
What types of violations has SMITHS MEDICAL INTERNATIONAL LTD. received?
SMITHS MEDICAL INTERNATIONAL LTD. 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 SMITHS MEDICAL INTERNATIONAL LTD. come from?
All FDA import refusal data for SMITHS MEDICAL INTERNATIONAL 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.