SCHOTT Schweiz AG
⚠️ High Risk
FEI: 3003671457 • Saint Gall, Saint Gall • SWITZERLAND
FEI Number
3003671457
Location
Saint Gall, Saint Gall
Country
SWITZERLANDAddress
St. Josefen-Strasse 20, , Saint Gall, Saint Gall, 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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2026 | 80PGOANTI-STICK GLASS SYRINGE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/8/2026 | 80PGOANTI-STICK GLASS SYRINGE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/30/2023 | 80DXTINJECTOR AND SYRINGE, ANGIOGRAPHIC | Division of Southeast Imports (DSEI) | |
| 2/26/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Northern Border Imports (DNBI) | |
| 9/7/2020 | 80FPKTUBING, FLUID DELIVERY | Division of Southeast Imports (DSEI) | |
| 7/22/2020 | 79GCBNEEDLE, CATHETER | Division of Northern Border Imports (DNBI) | |
| 9/12/2019 | 80FMFSYRINGE, PISTON | Division of Northern Border Imports (DNBI) | |
| 9/12/2019 | 80FMFSYRINGE, PISTON | Division of Northern Border Imports (DNBI) | |
| 6/10/2019 | 80PURVACUUM SYRINGE | Division of Northern Border Imports (DNBI) | |
| 3/26/2019 | 78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/26/2019 | 78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/26/2019 | 78FIHPUMP, INFUSION OR SYRINGE, EXTRA-LUMINAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/12/2018 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SCHOTT Schweiz AG's FDA import refusal history?
SCHOTT Schweiz AG (FEI: 3003671457) has 13 FDA import refusal record(s) in our database, spanning from 10/12/2018 to 1/8/2026.
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. SCHOTT Schweiz AG's FEI number is 3003671457.
What types of violations has SCHOTT Schweiz AG received?
SCHOTT Schweiz 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 SCHOTT Schweiz AG come from?
All FDA import refusal data for SCHOTT Schweiz 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.