BEAUTY BAY LIMITED
⚠️ Moderate Risk
FEI: 3016497192 • Manchester • UNITED KINGDOM
FEI Number
3016497192
Location
Manchester
Country
UNITED KINGDOMAddress
Davrom House, Lyoms Road, Manchester, , 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/15/2022 | 66PDY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/21/2022 | 80FYDAPPARATUS, EXHAUST, SURGICAL | Division of Southeast Imports (DSEI) | |
| 1/12/2022 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/1/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 9/1/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 7/23/2020 | 65LBL99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/5/2020 | 65LBL99PROTECTANT N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is BEAUTY BAY LIMITED's FDA import refusal history?
BEAUTY BAY LIMITED (FEI: 3016497192) has 7 FDA import refusal record(s) in our database, spanning from 6/5/2020 to 7/15/2022.
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. BEAUTY BAY LIMITED's FEI number is 3016497192.
What types of violations has BEAUTY BAY LIMITED received?
BEAUTY BAY LIMITED 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 BEAUTY BAY LIMITED come from?
All FDA import refusal data for BEAUTY BAY 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.