Dr Gustav Klein Gmbh & Co
⚠️ High Risk
FEI: 3005660741 • Zell am Harmersbach, Baden-Wurttemberg • GERMANY
FEI Number
3005660741
Location
Zell am Harmersbach, Baden-Wurttemberg
Country
GERMANYAddress
Steinenfeld 3, , Zell am Harmersbach, Baden-Wurttemberg, Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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).
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 Dr Gustav Klein Gmbh & Co's FDA import refusal history?
Dr Gustav Klein Gmbh & Co (FEI: 3005660741) has 1 FDA import refusal record(s) in our database, spanning from 1/21/2026 to 1/21/2026.
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. Dr Gustav Klein Gmbh & Co's FEI number is 3005660741.
What types of violations has Dr Gustav Klein Gmbh & Co received?
Dr Gustav Klein Gmbh & Co 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 Dr Gustav Klein Gmbh & Co come from?
All FDA import refusal data for Dr Gustav Klein 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.