White Lotus Anti Aging
⚠️ Moderate Risk
FEI: 3009659538 • Lewes, East Sussex • UNITED KINGDOM
FEI Number
3009659538
Location
Lewes, East Sussex
Country
UNITED KINGDOMAddress
4 Marbles Road, , Lewes, East Sussex, 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2012 | 77EPGSTIMULATOR, TRANSDERMAL | Cincinnati District Office (CIN-DO) | |
| 10/16/2012 | 77EPGSTIMULATOR, TRANSDERMAL | Cincinnati District Office (CIN-DO) | |
| 10/16/2012 | 77EPGSTIMULATOR, TRANSDERMAL | Cincinnati District Office (CIN-DO) | |
| 10/16/2012 | 77EPGSTIMULATOR, TRANSDERMAL | Cincinnati District Office (CIN-DO) | |
| 10/16/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/16/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/16/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/16/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 10/16/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/12/2012 | 77EPGSTIMULATOR, TRANSDERMAL | Cincinnati District Office (CIN-DO) | |
| 9/12/2012 | 77EPGSTIMULATOR, TRANSDERMAL | Cincinnati District Office (CIN-DO) | |
| 9/12/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/12/2012 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 9/12/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is White Lotus Anti Aging's FDA import refusal history?
White Lotus Anti Aging (FEI: 3009659538) has 14 FDA import refusal record(s) in our database, spanning from 9/12/2012 to 10/16/2012.
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. White Lotus Anti Aging's FEI number is 3009659538.
What types of violations has White Lotus Anti Aging received?
White Lotus Anti Aging 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 White Lotus Anti Aging come from?
All FDA import refusal data for White Lotus Anti Aging 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.