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Siemens Healthcare Diagnostics Inc.

⚠️ Moderate Risk

FEI: 1000122204 • Flanders, NJ • UNITED STATES

FEI

FEI Number

1000122204

📍

Location

Flanders, NJ

🇺🇸
🏢

Address

62 Flanders Bartley Rd, , Flanders, NJ, United States

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/4/2018
Latest Refusal
12/4/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

162×

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.

4792×

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
75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
16DIRECTIONS
479DV QUALITY
Division of Southeast Imports (DSEI)
12/4/2018
75CEWRADIOIMMUNOASSAY, PARATHYROID HORMONE
16DIRECTIONS
479DV QUALITY
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

Siemens Healthcare Diagnostics Inc. (FEI: 1000122204) has 2 FDA import refusal record(s) in our database, spanning from 12/4/2018 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 1000122204.

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

Siemens Healthcare Diagnostics Inc. has been cited for 2 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.