Wisdom Toothbrushes
⚠️ Moderate Risk
FEI: 1000211046 • Haverhill Suffolk, Suffolk • UNITED KINGDOM
FEI Number
1000211046
Location
Haverhill Suffolk, Suffolk
Country
UNITED KINGDOMAddress
The Silk Mill, , Haverhill Suffolk, Suffolk, 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).
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2013 | 76JESFLOSS, DENTAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/29/2013 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/29/2013 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/29/2013 | 76JESFLOSS, DENTAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/29/2013 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/29/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 4/29/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 4/29/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 4/29/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 10/19/2010 | 76EFWTOOTHBRUSH, MANUAL | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Wisdom Toothbrushes's FDA import refusal history?
Wisdom Toothbrushes (FEI: 1000211046) has 10 FDA import refusal record(s) in our database, spanning from 10/19/2010 to 4/29/2013.
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. Wisdom Toothbrushes's FEI number is 1000211046.
What types of violations has Wisdom Toothbrushes received?
Wisdom Toothbrushes has been cited for 5 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 Wisdom Toothbrushes come from?
All FDA import refusal data for Wisdom Toothbrushes 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.