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QED, Inc.

✅ Low Risk

FEI: 1037039 • Lexington, KY • UNITED STATES

FEI

FEI Number

1037039

📍

Location

Lexington, KY

🇺🇸
🏢

Address

750 Enterprise Dr, , Lexington, KY, United States

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/25/2002
Latest Refusal
11/25/2002
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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).

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).

Refusal History

DateProductViolationsDivision
11/25/2002
86FSRLIGHT, HEADBAND, SURGICAL
118NOT LISTED
341REGISTERED
Cincinnati District Office (CIN-DO)
11/25/2002
78FCWLIGHT SOURCE, FIBEROPTIC, ROUTINE
118NOT LISTED
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is QED, Inc.'s FDA import refusal history?

QED, Inc. (FEI: 1037039) has 2 FDA import refusal record(s) in our database, spanning from 11/25/2002 to 11/25/2002.

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. QED, Inc.'s FEI number is 1037039.

What types of violations has QED, Inc. received?

QED, 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 QED, Inc. come from?

All FDA import refusal data for QED, 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.