Siemens Ag

⚠️ Moderate Risk

FEI: 3001572641 • Erlangen, Bavaria • GERMANY

FEI

FEI Number

3001572641

📍

Location

Erlangen, Bavaria

🇩🇪

Country

GERMANY

🏢

Address

Karl-Zucker-Str. 14, , Erlangen, Bavaria, Germany

Moderate Risk

FDA Import Risk Assessment

39.7

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

10/24/2014

Latest Refusal

2/12/2007

Earliest Refusal

Score Breakdown

Violation Severity

72.0×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

9.1×10%

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

Violation Summary

1266×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

1182×

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).

5082×

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
10/24/2014	90IZLSYSTEM, X-RAY, MOBILE	118NOT LISTED 126FAILS STD 508NO 510(K)	Division of Southeast Imports (DSEI)
7/6/2012	74DQOCATHETER, INTRAVASCULAR, DIAGNOSTIC	118NOT LISTED 508NO 510(K)	New Orleans District Office (NOL-DO)
12/27/2011	95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL	126FAILS STD	New Orleans District Office (NOL-DO)
2/12/2007	90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC	126FAILS STD	New Orleans District Office (NOL-DO)
2/12/2007	90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC	126FAILS STD	New Orleans District Office (NOL-DO)
2/12/2007	90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC	126FAILS STD	New Orleans District Office (NOL-DO)
2/12/2007	90ITYASSEMBLY, TUBE HOUSING, X-RAY, DIAGNOSTIC	126FAILS STD	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Siemens Ag's FDA import refusal history?

Siemens Ag (FEI: 3001572641) has 7 FDA import refusal record(s) in our database, spanning from 2/12/2007 to 10/24/2014.

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 Ag's FEI number is 3001572641.

What types of violations has Siemens Ag received?

Siemens Ag has been cited for 3 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 Ag come from?

All FDA import refusal data for Siemens 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.