Len Bar
⚠️ Moderate Risk
FEI: 1000650934 • Chr • BARBADOS
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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2008 | 86HQLLENS, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 10/31/2007 | 86HQLLENS, INTRAOCULAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/20/2006 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | 237NO PMA | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 86HQLLENS, INTRAOCULAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 86HQLLENS, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 3/28/2005 | 86HQLLENS, INTRAOCULAR | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 12/14/2004 | 86HQLLENS, INTRAOCULAR | Florida District Office (FLA-DO) | |
| 12/3/2004 | 86HQLLENS, INTRAOCULAR | 508NO 510(K) | Florida District Office (FLA-DO) |
| 2/25/2004 | 86HQLLENS, INTRAOCULAR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 12/19/2003 | 86HQLLENS, INTRAOCULAR | 237NO PMA | New Orleans District Office (NOL-DO) |
| 6/26/2003 | 86HQLLENS, INTRAOCULAR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Len Bar's FDA import refusal history?
Len Bar (FEI: 1000650934) has 11 FDA import refusal record(s) in our database, spanning from 6/26/2003 to 5/7/2008.
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. Len Bar's FEI number is 1000650934.
What types of violations has Len Bar received?
Len Bar 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 Len Bar come from?
All FDA import refusal data for Len Bar 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.