Disetronic Medical Systems AG
⚠️ High Risk
FEI: 3004034924 • Burgdorf • SWITZERLAND
FEI Number
3004034924
Location
Burgdorf
Country
SWITZERLANDAddress
Kirchbergstrasse 190, , Burgdorf, , 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/1/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 5/31/2005 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 3/24/2005 | 80LZGPUMP, INFUSION, INSULIN | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 11/22/2004 | 80LZGPUMP, INFUSION, INSULIN | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 11/19/2004 | 80LZGPUMP, INFUSION, INSULIN | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Disetronic Medical Systems AG's FDA import refusal history?
Disetronic Medical Systems AG (FEI: 3004034924) has 10 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 9/26/2005.
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. Disetronic Medical Systems AG's FEI number is 3004034924.
What types of violations has Disetronic Medical Systems AG received?
Disetronic Medical Systems AG 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 Disetronic Medical Systems AG come from?
All FDA import refusal data for Disetronic Medical Systems 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.