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Crookes Healthcare Ltd

⚠️ Moderate Risk

FEI: 3003768311 • Nottingham • UNITED KINGDOM

FEI

FEI Number

3003768311

📍

Location

Nottingham

🇬🇧
🏢

Address

Unknown Street, , Nottingham, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/7/2002
Latest Refusal
10/7/2002
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

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).

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
10/7/2002
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Philadelphia District Office (PHI-DO)
10/7/2002
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Crookes Healthcare Ltd's FDA import refusal history?

Crookes Healthcare Ltd (FEI: 3003768311) has 2 FDA import refusal record(s) in our database, spanning from 10/7/2002 to 10/7/2002.

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. Crookes Healthcare Ltd's FEI number is 3003768311.

What types of violations has Crookes Healthcare Ltd received?

Crookes Healthcare 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 Crookes Healthcare Ltd come from?

All FDA import refusal data for Crookes Healthcare 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.