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Mone Medikal A.S.

⚠️ Moderate Risk

FEI: 3009061908 • Istanbul, Corum • TURKEY

FEI

FEI Number

3009061908

📍

Location

Istanbul, Corum

🇹🇷

Country

TURKEY
🏢

Address

Organize, , Istanbul, Corum, Turkey

Moderate Risk

FDA Import Risk Assessment

37.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
10/6/2010
Latest Refusal
10/6/2010
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

5085×

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

DateProductViolationsDivision
10/6/2010
80FRKCHAIR, EXAMINATION AND TREATMENT
118NOT LISTED
508NO 510(K)
Minneapolis District Office (MIN-DO)
10/6/2010
80FNJBED, MANUAL
118NOT LISTED
508NO 510(K)
Minneapolis District Office (MIN-DO)
10/6/2010
80FRKCHAIR, EXAMINATION AND TREATMENT
118NOT LISTED
508NO 510(K)
Minneapolis District Office (MIN-DO)
10/6/2010
80FMLCHAIR, BLOOD DONOR
118NOT LISTED
508NO 510(K)
Minneapolis District Office (MIN-DO)
10/6/2010
80FRKCHAIR, EXAMINATION AND TREATMENT
118NOT LISTED
508NO 510(K)
Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Mone Medikal A.S.'s FDA import refusal history?

Mone Medikal A.S. (FEI: 3009061908) has 5 FDA import refusal record(s) in our database, spanning from 10/6/2010 to 10/6/2010.

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. Mone Medikal A.S.'s FEI number is 3009061908.

What types of violations has Mone Medikal A.S. received?

Mone Medikal A.S. 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 Mone Medikal A.S. come from?

All FDA import refusal data for Mone Medikal A.S. 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.