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Huntercombe Lane South

⚠️ Moderate Risk

FEI: 3004871185 • Berkshire • UNITED KINGDOM

FEI

FEI Number

3004871185

📍

Location

Berkshire

🇬🇧
🏢

Address

Taplow, , Berkshire, , 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
1
Unique Violations
2/17/2005
Latest Refusal
2/17/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
2/17/2005
57CC02INFLUENZA VIRUS VACCINE
27DRUG GMPS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Huntercombe Lane South's FDA import refusal history?

Huntercombe Lane South (FEI: 3004871185) has 1 FDA import refusal record(s) in our database, spanning from 2/17/2005 to 2/17/2005.

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. Huntercombe Lane South's FEI number is 3004871185.

What types of violations has Huntercombe Lane South received?

Huntercombe Lane South has been cited for 1 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 Huntercombe Lane South come from?

All FDA import refusal data for Huntercombe Lane South 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.