Siemens Healthcare Diagnostics Inc
⚠️ Moderate Risk
FEI: 1824828 • Elkhart, IN • UNITED STATES
FEI Number
1824828
Location
Elkhart, IN
Country
UNITED STATESAddress
3400 Middlebury St, , Elkhart, IN, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2004 | 75CGAGLUCOSE OXIDASE, GLUCOSE | New York District Office (NYK-DO) | |
| 12/2/2004 | 75CGAGLUCOSE OXIDASE, GLUCOSE | New York District Office (NYK-DO) | |
| 1/27/2004 | 75CGAGLUCOSE OXIDASE, GLUCOSE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Siemens Healthcare Diagnostics Inc's FDA import refusal history?
Siemens Healthcare Diagnostics Inc (FEI: 1824828) has 3 FDA import refusal record(s) in our database, spanning from 1/27/2004 to 12/2/2004.
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 Healthcare Diagnostics Inc's FEI number is 1824828.
What types of violations has Siemens Healthcare Diagnostics Inc received?
Siemens Healthcare Diagnostics Inc 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 Siemens Healthcare Diagnostics Inc come from?
All FDA import refusal data for Siemens Healthcare Diagnostics 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.