SCOTTISH FINE SOAPS LTD
⚠️ Moderate Risk
FEI: 3012434216 • Falkirk, FAL • UNITED KINGDOM
FEI Number
3012434216
Location
Falkirk, FAL
Country
UNITED KINGDOMAddress
North Main Street, Fal, Falkirk, FAL, 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).
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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 2/25/2013 | 61FBL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Chicago District Office (CHI-DO) | |
| 12/15/2009 | 61HBL99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SCOTTISH FINE SOAPS LTD's FDA import refusal history?
SCOTTISH FINE SOAPS LTD (FEI: 3012434216) has 3 FDA import refusal record(s) in our database, spanning from 12/15/2009 to 3/7/2013.
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. SCOTTISH FINE SOAPS LTD's FEI number is 3012434216.
What types of violations has SCOTTISH FINE SOAPS LTD received?
SCOTTISH FINE SOAPS LTD 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 SCOTTISH FINE SOAPS LTD come from?
All FDA import refusal data for SCOTTISH FINE SOAPS 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.