Crookes Healthcare Ltd
⚠️ Moderate Risk
FEI: 3004592966 • Nottingham • UNITED KINGDOM
FEI Number
3004592966
Location
Nottingham
Country
UNITED KINGDOMAddress
Central Park, Lenton Lane, Nottingham, , United Kingdom
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/21/2007 | 62GAY41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/5/2006 | 55PP31BENZYL ALCOHOL (PHARMACEUTIC NECESSITY - ANTIMICROBIAL AGENT) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/14/2006 | 61EBK01CROMOLYN SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/17/2006 | 62UAY99ANTI-TUSSIVE/COLD N.E.C. | New York District Office (NYK-DO) | |
| 6/7/2005 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Crookes Healthcare Ltd's FDA import refusal history?
Crookes Healthcare Ltd (FEI: 3004592966) has 5 FDA import refusal record(s) in our database, spanning from 6/7/2005 to 6/21/2007.
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 3004592966.
What types of violations has Crookes Healthcare Ltd received?
Crookes Healthcare Ltd has been cited for 3 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.