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General Healthcare Limited

⚠️ Moderate Risk

FEI: 3002482459 • Hayes • UNITED KINGDOM

FEI

FEI Number

3002482459

📍

Location

Hayes

🇬🇧
🏢

Address

111 Blyth Road, , Hayes, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

30.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/5/2009
Latest Refusal
12/20/2004
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
6.7×10%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/5/2009
53GC09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
12/20/2004
55QY31COLD CREAM (PHARMACEUTIC NECESSITY - WATER IN OIL EMULSION)
473LABELING
Florida District Office (FLA-DO)
12/20/2004
55QY31COLD CREAM (PHARMACEUTIC NECESSITY - WATER IN OIL EMULSION)
473LABELING
Florida District Office (FLA-DO)

Frequently Asked Questions

What is General Healthcare Limited's FDA import refusal history?

General Healthcare Limited (FEI: 3002482459) has 3 FDA import refusal record(s) in our database, spanning from 12/20/2004 to 6/5/2009.

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. General Healthcare Limited's FEI number is 3002482459.

What types of violations has General Healthcare Limited received?

General Healthcare Limited 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 General Healthcare Limited come from?

All FDA import refusal data for General Healthcare Limited 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.