Grafox Chemie Vertriebs Gmbh
⚠️ Moderate Risk
FEI: 3000286624 • Babenhausen • GERMANY
FEI Number
3000286624
Location
Babenhausen
Country
GERMANYAddress
Hergershauser Strasse 25, , Babenhausen, , 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
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.
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).
Refusal History
Frequently Asked Questions
What is Grafox Chemie Vertriebs Gmbh's FDA import refusal history?
Grafox Chemie Vertriebs Gmbh (FEI: 3000286624) has 1 FDA import refusal record(s) in our database, spanning from 5/7/2003 to 5/7/2003.
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. Grafox Chemie Vertriebs Gmbh's FEI number is 3000286624.
What types of violations has Grafox Chemie Vertriebs Gmbh received?
Grafox Chemie Vertriebs Gmbh has been cited for 2 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 Grafox Chemie Vertriebs Gmbh come from?
All FDA import refusal data for Grafox Chemie Vertriebs 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.