SSL INTERNATIONAL, PLC
⚠️ Moderate Risk
FEI: 3007345450 • Manchester • UNITED KINGDOM
FEI Number
3007345450
Location
Manchester
Country
UNITED KINGDOMAddress
Old Park Lane, , 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).
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 475COSMETLBLG | Cincinnati District Office (CIN-DO) |
| 4/3/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 4/3/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 4/3/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 4/3/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 4/3/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/31/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/31/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/31/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/31/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/31/2015 | 85HISCONDOM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is SSL INTERNATIONAL, PLC's FDA import refusal history?
SSL INTERNATIONAL, PLC (FEI: 3007345450) has 11 FDA import refusal record(s) in our database, spanning from 3/31/2015 to 4/3/2015.
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. SSL INTERNATIONAL, PLC's FEI number is 3007345450.
What types of violations has SSL INTERNATIONAL, PLC received?
SSL INTERNATIONAL, PLC has been cited for 7 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 SSL INTERNATIONAL, PLC come from?
All FDA import refusal data for SSL INTERNATIONAL, PLC 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.