Tdi Online
⚠️ High Risk
FEI: 3009207515 • Watford • UNITED KINGDOM
FEI Number
3009207515
Location
Watford
Country
UNITED KINGDOMAddress
3 Woodshots Meadow, , Watford, , United Kingdom
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2012 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/2/2012 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 2/10/2012 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 2/10/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 1/6/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 1/6/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 12/29/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 12/20/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/20/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/16/2011 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/16/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/16/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/16/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/6/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/2/2011 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tdi Online's FDA import refusal history?
Tdi Online (FEI: 3009207515) has 25 FDA import refusal record(s) in our database, spanning from 12/2/2011 to 3/5/2012.
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. Tdi Online's FEI number is 3009207515.
What types of violations has Tdi Online received?
Tdi Online 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 Tdi Online come from?
All FDA import refusal data for Tdi Online 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.