Siemens Medical Solutions USA, Inc.
✅ Low Risk
FEI: 1000514697 • Hoffman Estates, IL • UNITED STATES
FEI Number
1000514697
Location
Hoffman Estates, IL
Country
UNITED STATESAddress
2501 Barrington Rd, , Hoffman Estates, IL, United States
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2013 | 79LRRKIT, FIRST AID | 118NOT LISTED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Siemens Medical Solutions USA, Inc.'s FDA import refusal history?
Siemens Medical Solutions USA, Inc. (FEI: 1000514697) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2013 to 5/3/2013.
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. Siemens Medical Solutions USA, Inc.'s FEI number is 1000514697.
What types of violations has Siemens Medical Solutions USA, Inc. received?
Siemens Medical Solutions USA, Inc. has been cited for 1 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 Siemens Medical Solutions USA, Inc. come from?
All FDA import refusal data for Siemens Medical Solutions USA, Inc. 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.