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ABB Optical Group LLC

⚠️ Moderate Risk

FEI: 2916547 • Kansas City, MO • UNITED STATES

FEI

FEI Number

2916547

📍

Location

Kansas City, MO

🇺🇸
🏢

Address

3901 Ne 33rd Ter, , Kansas City, MO, United States

Moderate Risk

FDA Import Risk Assessment

25.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
9/12/2012
Latest Refusal
8/7/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.5×10%
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

1181×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3411×

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

DateProductViolationsDivision
9/12/2012
86MVNLENS, CONTACT (DISPOSABLE)
16DIRECTIONS
341REGISTERED
Cincinnati District Office (CIN-DO)
8/7/2009
86LPLLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is ABB Optical Group LLC's FDA import refusal history?

ABB Optical Group LLC (FEI: 2916547) has 2 FDA import refusal record(s) in our database, spanning from 8/7/2009 to 9/12/2012.

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. ABB Optical Group LLC's FEI number is 2916547.

What types of violations has ABB Optical Group LLC received?

ABB Optical Group LLC 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 ABB Optical Group LLC come from?

All FDA import refusal data for ABB Optical Group LLC 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.