CU Chemie Uetikon GmbH
⚠️ Moderate Risk
FEI: 3002806757 • Lahr, Baden-Wurttemberg • GERMANY
FEI Number
3002806757
Location
Lahr, Baden-Wurttemberg
Country
GERMANYAddress
Raiffeisenstr. 4, , Lahr, 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2018 | 60QCT03KETAMINE HCL (ANESTHETIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/13/2018 | 60QCT03KETAMINE HCL (ANESTHETIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/13/2018 | 60QCT03KETAMINE HCL (ANESTHETIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 6/18/2015 | 60QIT03KETAMINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/18/2015 | 60QIT03KETAMINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/26/2014 | 60QIS03KETAMINE HCL (ANESTHETIC) | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 1/18/2007 | 60QCS03KETAMINE HCL (ANESTHETIC) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 11/17/2004 | 66KCS01METHIMAZOLE (THYROID INHIBITOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is CU Chemie Uetikon GmbH's FDA import refusal history?
CU Chemie Uetikon GmbH (FEI: 3002806757) has 8 FDA import refusal record(s) in our database, spanning from 11/17/2004 to 6/19/2018.
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. CU Chemie Uetikon GmbH's FEI number is 3002806757.
What types of violations has CU Chemie Uetikon GmbH received?
CU Chemie Uetikon 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 CU Chemie Uetikon GmbH come from?
All FDA import refusal data for CU Chemie Uetikon 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.