Orean Personal Care Ltd
⚠️ Moderate Risk
FEI: 3010999645 • Cleckheaton, West Yorkshire • UNITED KINGDOM
FEI Number
3010999645
Location
Cleckheaton, West Yorkshire
Country
UNITED KINGDOMAddress
Unit E1, Stubs Beck Lane, Cleckheaton, West Yorkshire, 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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2015 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/14/2014 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | Detroit District Office (DET-DO) |
| 1/14/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 1/14/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 7/24/2012 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Orean Personal Care Ltd's FDA import refusal history?
Orean Personal Care Ltd (FEI: 3010999645) has 5 FDA import refusal record(s) in our database, spanning from 7/24/2012 to 10/30/2015.
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. Orean Personal Care Ltd's FEI number is 3010999645.
What types of violations has Orean Personal Care Ltd received?
Orean Personal Care Ltd has been cited for 4 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 Orean Personal Care Ltd come from?
All FDA import refusal data for Orean Personal Care 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.