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Lenstec (Barbados) Inc.

⚠️ Moderate Risk

FEI: 3001284430 • Christ Church, Christ Church • BARBADOS

FEI

FEI Number

3001284430

📍

Location

Christ Church, Christ Church

🇧🇧

Country

BARBADOS
🏢

Address

Airport Commercial Centre, Pilgrim Road, , Christ Church, Christ Church, Barbados

Moderate Risk

FDA Import Risk Assessment

25.8
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
10/5/2011
Latest Refusal
12/14/2004
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.4×10%
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

3412×

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).

2371×

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).

Refusal History

DateProductViolationsDivision
10/5/2011
86HQLLENS, INTRAOCULAR
341REGISTERED
New Orleans District Office (NOL-DO)
5/15/2006
86HQLLENS, INTRAOCULAR
341REGISTERED
Florida District Office (FLA-DO)
12/14/2004
86HQLLENS, INTRAOCULAR
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Lenstec (Barbados) Inc.'s FDA import refusal history?

Lenstec (Barbados) Inc. (FEI: 3001284430) has 3 FDA import refusal record(s) in our database, spanning from 12/14/2004 to 10/5/2011.

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. Lenstec (Barbados) Inc.'s FEI number is 3001284430.

What types of violations has Lenstec (Barbados) Inc. received?

Lenstec (Barbados) Inc. has been cited for 2 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 Lenstec (Barbados) Inc. come from?

All FDA import refusal data for Lenstec (Barbados) Inc. 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.