Mt.Derm Gmbh
⚠️ Moderate Risk
FEI: 3006634874 • Berlin, Berlin • GERMANY
FEI Number
3006634874
Location
Berlin, Berlin
Country
GERMANYAddress
Gustav-Krone-Str. 3, , Berlin, Berlin, Germany
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
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.
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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 6/26/2024 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/20/2023 | 79QAIPOWERED MICRONEEDLE DEVICE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 80LDQDEVICE, GENERAL MEDICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 4/24/2017 | 79GEDBRUSH, DERMABRASION, MANUAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 10/21/2015 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | New Orleans District Office (NOL-DO) | |
| 5/21/2015 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | Florida District Office (FLA-DO) | |
| 6/3/2011 | 79GCBNEEDLE, CATHETER | 118NOT LISTED | New York District Office (NYK-DO) |
| 5/20/2009 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mt.Derm Gmbh's FDA import refusal history?
Mt.Derm Gmbh (FEI: 3006634874) has 8 FDA import refusal record(s) in our database, spanning from 5/20/2009 to 6/26/2024.
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. Mt.Derm Gmbh's FEI number is 3006634874.
What types of violations has Mt.Derm Gmbh received?
Mt.Derm Gmbh 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 Mt.Derm Gmbh come from?
All FDA import refusal data for Mt.Derm Gmbh 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.