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Duckworth & Kent, Ltd.

⚠️ Moderate Risk

FEI: 1000231766 • Baldock, Hertfordshire • UNITED KINGDOM

FEI

FEI Number

1000231766

📍

Location

Baldock, Hertfordshire

🇬🇧
🏢

Address

Terence House, 7 Marquis Business Centre; Royston Road, Baldock, Hertfordshire, United Kingdom

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/8/2025
Latest Refusal
1/8/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
79.6×20%
Frequency
10.0×10%
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

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).

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
1/8/2025
86HQNCONFORMER, OPHTHALMIC
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Duckworth & Kent, Ltd.'s FDA import refusal history?

Duckworth & Kent, Ltd. (FEI: 1000231766) has 1 FDA import refusal record(s) in our database, spanning from 1/8/2025 to 1/8/2025.

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. Duckworth & Kent, Ltd.'s FEI number is 1000231766.

What types of violations has Duckworth & Kent, Ltd. received?

Duckworth & Kent, Ltd. 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 Duckworth & Kent, Ltd. come from?

All FDA import refusal data for Duckworth & Kent, Ltd. 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.