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Designs For Vision, Inc.

✅ Low Risk

FEI: 2431764 • Bohemia, NY • UNITED STATES

FEI

FEI Number

2431764

📍

Location

Bohemia, NY

🇺🇸
🏢

Address

4000 Veterans Memorial Hwy, , Bohemia, NY, United States

Low Risk

FDA Import Risk Assessment

24.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
2
Unique Violations
11/26/2014
Latest Refusal
12/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
7.5×10%
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

1182×

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).

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
11/26/2014
79FSPLOUPE, DIAGNOSTIC/SURGICAL
341REGISTERED
Division of Northern Border Imports (DNBI)
12/3/2010
78GCTLIGHT SOURCE, ENDOSCOPE, XENON ARC
118NOT LISTED
New York District Office (NYK-DO)
12/3/2010
79FSPLOUPE, DIAGNOSTIC/SURGICAL
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Designs For Vision, Inc.'s FDA import refusal history?

Designs For Vision, Inc. (FEI: 2431764) has 3 FDA import refusal record(s) in our database, spanning from 12/3/2010 to 11/26/2014.

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. Designs For Vision, Inc.'s FEI number is 2431764.

What types of violations has Designs For Vision, Inc. received?

Designs For Vision, 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 Designs For Vision, Inc. come from?

All FDA import refusal data for Designs For Vision, 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.