Dottikon Exclusive Synthesis AG
⚠️ Moderate Risk
FEI: 3002806909 • Dottikon, Aargau • SWITZERLAND
FEI Number
3002806909
Location
Dottikon, Aargau
Country
SWITZERLANDAddress
Hembrunnstrasse 17, , Dottikon, Aargau, Switzerland
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
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).
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 |
|---|---|---|---|
| 10/11/2022 | 62ICY99ANTI-NEOPLASTIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/11/2022 | 62ICY99ANTI-NEOPLASTIC N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/2/2005 | 66VIS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/14/2004 | 66SCS24ISOSORBIDE DINITRATE (VASODILATOR) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dottikon Exclusive Synthesis AG's FDA import refusal history?
Dottikon Exclusive Synthesis AG (FEI: 3002806909) has 4 FDA import refusal record(s) in our database, spanning from 12/14/2004 to 10/11/2022.
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. Dottikon Exclusive Synthesis AG's FEI number is 3002806909.
What types of violations has Dottikon Exclusive Synthesis AG received?
Dottikon Exclusive Synthesis AG 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 Dottikon Exclusive Synthesis AG come from?
All FDA import refusal data for Dottikon Exclusive Synthesis AG 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.