Mapa Gmbh
⚠️ Moderate Risk
FEI: 3002807642 • Zeven, Lower Saxony • GERMANY
FEI Number
3002807642
Location
Zeven, Lower Saxony
Country
GERMANYAddress
Industriestr. 21-25, , Zeven, Lower Saxony, 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
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).
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).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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 |
|---|---|---|---|
| 11/23/2022 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 5/16/2014 | 85HISCONDOM | 290DE IMP GMP | Chicago District Office (CHI-DO) |
| 11/15/2010 | 85HISCONDOM | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 11/3/2010 | 85HISCONDOM | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Mapa Gmbh's FDA import refusal history?
Mapa Gmbh (FEI: 3002807642) has 4 FDA import refusal record(s) in our database, spanning from 11/3/2010 to 11/23/2022.
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. Mapa Gmbh's FEI number is 3002807642.
What types of violations has Mapa Gmbh received?
Mapa Gmbh has been cited for 4 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 Mapa Gmbh come from?
All FDA import refusal data for Mapa 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.