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Bayer Health Care

⚠️ Moderate Risk

FEI: 3005940265 • Istanbul • TURKEY

FEI

FEI Number

3005940265

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Cakmark Mahaliesi No 53, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/22/2017
Latest Refusal
8/22/2017
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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.

Refusal History

DateProductViolationsDivision
8/22/2017
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
16DIRECTIONS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Bayer Health Care's FDA import refusal history?

Bayer Health Care (FEI: 3005940265) has 1 FDA import refusal record(s) in our database, spanning from 8/22/2017 to 8/22/2017.

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. Bayer Health Care's FEI number is 3005940265.

What types of violations has Bayer Health Care received?

Bayer Health Care 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 Bayer Health Care come from?

All FDA import refusal data for Bayer Health Care 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.