Similasan AG
⚠️ High Risk
FEI: 1000110034 • Jonen, Aargau • SWITZERLAND
FEI Number
1000110034
Location
Jonen, Aargau
Country
SWITZERLANDAddress
Chriesiweg 6, , Jonen, Aargau, Switzerland
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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 |
|---|---|---|---|
| 8/22/2025 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/4/2025 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 1/8/2025 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 2/21/2024 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 9/22/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 9/7/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/31/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/31/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/31/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/29/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/29/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/29/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/29/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/29/2023 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/10/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/10/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/10/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/10/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/10/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/10/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 7/26/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 7/26/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 7/26/2023 | 66YBK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 10/5/2021 | 61KBK06BELLADONNA (EXT) (ANTI-CHOLINERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 61KBK06BELLADONNA (EXT) (ANTI-CHOLINERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 61KBK06BELLADONNA (EXT) (ANTI-CHOLINERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 61KBK06BELLADONNA (EXT) (ANTI-CHOLINERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/5/2021 | 61KBK06BELLADONNA (EXT) (ANTI-CHOLINERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/5/2011 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 223FALSE | Southwest Import District Office (SWI-DO) |
| 12/5/2011 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 223FALSE | Southwest Import District Office (SWI-DO) |
| 12/5/2011 | 66YBL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 223FALSE | Southwest Import District Office (SWI-DO) |
| 7/5/2011 | 54FEK35BELLADONNA (HERBAL & BOTANICALS, NOT TEAS) | Chicago District Office (CHI-DO) | |
| 6/3/2011 | 54FEK35BELLADONNA (HERBAL & BOTANICALS, NOT TEAS) | Chicago District Office (CHI-DO) | |
| 6/3/2011 | 54FEK35BELLADONNA (HERBAL & BOTANICALS, NOT TEAS) | Chicago District Office (CHI-DO) | |
| 6/3/2011 | 54FEK35BELLADONNA (HERBAL & BOTANICALS, NOT TEAS) | Chicago District Office (CHI-DO) | |
| 4/13/2011 | 54FGL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/13/2011 | 54FEK35BELLADONNA (HERBAL & BOTANICALS, NOT TEAS) | Southwest Import District Office (SWI-DO) | |
| 4/13/2011 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 4/13/2011 | 54FGL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/13/2011 | 54FES99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/13/2011 | 54FEK99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Similasan AG's FDA import refusal history?
Similasan AG (FEI: 1000110034) has 42 FDA import refusal record(s) in our database, spanning from 4/13/2011 to 8/22/2025.
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. Similasan AG's FEI number is 1000110034.
What types of violations has Similasan AG received?
Similasan AG has been cited for 7 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 Similasan AG come from?
All FDA import refusal data for Similasan 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.