Cannon Rubber Ltd
⚠️ Moderate Risk
FEI: 1000358444 • London • UNITED KINGDOM
FEI Number
1000358444
Location
London
Country
UNITED KINGDOMAddress
Ashley Road, Tottenham, London, , 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
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).
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 |
|---|---|---|---|
| 8/17/2005 | 80HFSSHIELD, NIPPLE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/17/2005 | 74DWMAPPARATUS, SUCTION, PATIENT CARE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 1/14/2005 | 76KKORING, TEETHING, FLUID-FILLED | Division of Southeast Imports (DSEI) | |
| 1/14/2005 | 80HFSSHIELD, NIPPLE | Division of Southeast Imports (DSEI) | |
| 1/14/2005 | 85HGYPUMP, BREAST, NON-POWERED | Division of Southeast Imports (DSEI) | |
| 12/13/2004 | 53AY99OTHER BABY PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 12/13/2004 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/13/2004 | 53BF99OTHER BATH PREPARATIONS, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/3/2004 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 11/3/2004 | 53AY99OTHER BABY PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/3/2004 | 53BF99OTHER BATH PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/9/2004 | 53AF99OTHER BABY PRODUCTS, N.E.C. | 341REGISTERED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Cannon Rubber Ltd's FDA import refusal history?
Cannon Rubber Ltd (FEI: 1000358444) has 12 FDA import refusal record(s) in our database, spanning from 4/9/2004 to 8/17/2005.
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. Cannon Rubber Ltd's FEI number is 1000358444.
What types of violations has Cannon Rubber Ltd received?
Cannon Rubber 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 Cannon Rubber Ltd come from?
All FDA import refusal data for Cannon Rubber 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.