Giesen Forsthoff Gmbh Co
✅ Low Risk
FEI: 3002716547 • Solingen, North Rhine-Westphalia • GERMANY
FEI Number
3002716547
Location
Solingen, North Rhine-Westphalia
Country
GERMANYAddress
Baumstr. 36-38, , Solingen, North Rhine-Westphalia, Germany
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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).
Refusal History
Frequently Asked Questions
What is Giesen Forsthoff Gmbh Co's FDA import refusal history?
Giesen Forsthoff Gmbh Co (FEI: 3002716547) has 1 FDA import refusal record(s) in our database, spanning from 11/12/2014 to 11/12/2014.
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. Giesen Forsthoff Gmbh Co's FEI number is 3002716547.
What types of violations has Giesen Forsthoff Gmbh Co received?
Giesen Forsthoff Gmbh Co 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 Giesen Forsthoff Gmbh Co come from?
All FDA import refusal data for Giesen Forsthoff Gmbh Co 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.