Mentolatum Company LTD.
⚠️ Moderate Risk
FEI: 3008615590 • Glasgow, SLK • UNITED KINGDOM
FEI Number
3008615590
Location
Glasgow, SLK
Country
UNITED KINGDOMAddress
1 Redwood Avenue, None Of The Above, Glasgow, SLK, 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).
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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.
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 |
|---|---|---|---|
| 3/8/2024 | 62MAJ08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 2/15/2024 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 7/25/2022 | 62MBY08MENTHOL (ANTI-PRURITIC) | Division of Southeast Imports (DSEI) | |
| 5/24/2017 | 62GBJ41IBUPROFEN (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 6/7/2012 | 76EHSCUSHION, DENTURE, OTC | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 5/9/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 6/28/2011 | 66VCC99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 6/11/2010 | 62GDJ41IBUPROFEN (ANTI-INFLAMMATORY) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Mentolatum Company LTD.'s FDA import refusal history?
Mentolatum Company LTD. (FEI: 3008615590) has 8 FDA import refusal record(s) in our database, spanning from 6/11/2010 to 3/8/2024.
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. Mentolatum Company LTD.'s FEI number is 3008615590.
What types of violations has Mentolatum Company LTD. received?
Mentolatum Company LTD. 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 Mentolatum Company LTD. come from?
All FDA import refusal data for Mentolatum Company 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.