Schiller, Ag
⚠️ High Risk
FEI: 3002808182 • Baar, Zug • SWITZERLAND
FEI Number
3002808182
Location
Baar, Zug
Country
SWITZERLANDAddress
Altgasse 68, , Baar, Zug, 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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/3/2025 | 74DPSELECTROCARDIOGRAPH | Division of West Coast Imports (DWCI) | |
| 10/31/2023 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | Division of Southeast Imports (DSEI) | |
| 10/31/2023 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | Division of Southeast Imports (DSEI) | |
| 8/23/2023 | 74DPSELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 11/7/2019 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | Division of Southeast Imports (DSEI) | |
| 5/24/2019 | 74NSAOVER-THE-COUNTER AUTOMATED EXTERNAL DEFIBRILLATOR | Division of Southeast Imports (DSEI) | |
| 9/9/2016 | 80CBDBOTTLE, COLLECTION, BREATHING SYSTEM (CALIBRATED) | Division of Southeast Imports (DSEI) | |
| 7/22/2014 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | 341REGISTERED | Cincinnati District Office (CIN-DO) |
| 11/1/2013 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 11/1/2013 | 74DSHRECORDER, MAGNETIC TAPE, MEDICAL | Florida District Office (FLA-DO) | |
| 2/6/2013 | 74DRKDC-DEFIBRILLATOR, HIGH ENERGY, (INCLUDING PADDLES) | Division of Southeast Imports (DSEI) | |
| 2/25/2011 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/16/2004 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 7/16/2004 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 7/16/2004 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 6/18/2002 | 74DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE | San Francisco District Office (SAN-DO) | |
| 6/3/2002 | 74MHXMONITOR, PHYSIOLOGICAL, PATIENT | Florida District Office (FLA-DO) | |
| 6/3/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 6/3/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 6/3/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 6/3/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 6/3/2002 | 74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM | Florida District Office (FLA-DO) | |
| 5/16/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 5/16/2002 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) | |
| 4/16/2002 | 74MPDAUXILLARY POWER SUPPLY (AC OR DC) FOR LOW-ENERGY DC-DEFIBRILLATOR | Florida District Office (FLA-DO) | |
| 12/27/2001 | 74KRKMANOMETER, BLOOD-PRESSURE, VENOUS | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Schiller, Ag's FDA import refusal history?
Schiller, Ag (FEI: 3002808182) has 26 FDA import refusal record(s) in our database, spanning from 12/27/2001 to 6/3/2025.
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. Schiller, Ag's FEI number is 3002808182.
What types of violations has Schiller, Ag received?
Schiller, Ag has been cited for 4 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 Schiller, Ag come from?
All FDA import refusal data for Schiller, 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.