WEBER MEDICAL GMBH
⚠️ Moderate Risk
FEI: 3007165178 • Lauenforde, Lower Saxony • GERMANY
FEI Number
3007165178
Location
Lauenforde, Lower Saxony
Country
GERMANYAddress
Sohnreystr. 4, , Lauenforde, 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
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).
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).
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/29/2018 | 41BYT99FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | Division of Northern Border Imports (DNBI) | |
| 3/10/2016 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | 341REGISTERED | Florida District Office (FLA-DO) |
| 6/8/2012 | 74DQRCANNULA, CATHETER | 118NOT LISTED | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is WEBER MEDICAL GMBH's FDA import refusal history?
WEBER MEDICAL GMBH (FEI: 3007165178) has 3 FDA import refusal record(s) in our database, spanning from 6/8/2012 to 5/29/2018.
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. WEBER MEDICAL GMBH's FEI number is 3007165178.
What types of violations has WEBER MEDICAL GMBH received?
WEBER MEDICAL 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 WEBER MEDICAL GMBH come from?
All FDA import refusal data for WEBER MEDICAL 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.