Ssl International Plc
⚠️ Moderate Risk
FEI: 3003314681 • Cheshire • UNITED KINGDOM
FEI Number
3003314681
Location
Cheshire
Country
UNITED KINGDOMAddress
Canute Court Toft Road Knutsford, , Cheshire, , 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 6/6/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/3/2003 | 66PAL05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ssl International Plc's FDA import refusal history?
Ssl International Plc (FEI: 3003314681) has 3 FDA import refusal record(s) in our database, spanning from 6/3/2003 to 8/22/2006.
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 3003314681.
What types of violations has Ssl International Plc received?
Ssl International Plc 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 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.