ImportRefusal LogoImportRefusal

Siemens Healthcare Diagnostics, Inc.

⚠️ Moderate Risk

FEI: 2432235 • Tarrytown, NY • UNITED STATES

FEI

FEI Number

2432235

📍

Location

Tarrytown, NY

🇺🇸
🏢

Address

511 Benedict Ave, , Tarrytown, NY, United States

Moderate Risk

FDA Import Risk Assessment

29.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
5
Unique Violations
12/4/2018
Latest Refusal
9/1/2011
Earliest Refusal

Score Breakdown

Violation Severity
56.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.1×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

1181×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

3411×

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).

4791×

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.

Refusal History

DateProductViolationsDivision
12/4/2018
75CGNACID, FOLIC, RADIOIMMUNOASSAY
16DIRECTIONS
479DV QUALITY
Division of Southeast Imports (DSEI)
12/6/2012
75OIEURINE COLLECTION KIT (EXCLUDES HIV TESTING)
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)
9/1/2011
57UH02ANTIHEMOPHILIC FACTOR
179AGR RX
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Siemens Healthcare Diagnostics, Inc.'s FDA import refusal history?

Siemens Healthcare Diagnostics, Inc. (FEI: 2432235) has 3 FDA import refusal record(s) in our database, spanning from 9/1/2011 to 12/4/2018.

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 2432235.

What types of violations has Siemens Healthcare Diagnostics, Inc. received?

Siemens Healthcare Diagnostics, Inc. has been cited for 5 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.