Chemcon GmbH
⚠️ Moderate Risk
FEI: 3002553230 • Freiburg im Breisgau, Baden-Wurttemberg • GERMANY
FEI Number
3002553230
Location
Freiburg im Breisgau, Baden-Wurttemberg
Country
GERMANYAddress
Engesserstr. 4b, , Freiburg im Breisgau, Baden-Wurttemberg, 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
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).
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).
Refusal History
Frequently Asked Questions
What is Chemcon GmbH's FDA import refusal history?
Chemcon GmbH (FEI: 3002553230) has 3 FDA import refusal record(s) in our database, spanning from 6/16/2010 to 12/23/2016.
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. Chemcon GmbH's FEI number is 3002553230.
What types of violations has Chemcon GmbH received?
Chemcon 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 Chemcon GmbH come from?
All FDA import refusal data for Chemcon 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.