M.d. International, Inc.

⚠️ Moderate Risk

FEI: 1000114102 • Doral, FL • UNITED STATES

FEI

FEI Number

1000114102

📍

Location

Doral, FL

🇺🇸

Country

UNITED STATES

🏢

Address

11300 NW 41st St, , Doral, FL, United States

Moderate Risk

FDA Import Risk Assessment

49.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/25/2004

Latest Refusal

6/25/2004

Earliest Refusal

Score Breakdown

Violation Severity

65.0×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

47614×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

50814×

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
6/25/2004	79LRWSCISSORS, GENERAL USE, SURGICAL	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	87HXBPROBE	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	79EMFKNIFE, SURGICAL	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	79HTDFORCEPS	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	79LRWSCISSORS, GENERAL USE, SURGICAL	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	79HTCPLIERS, SURGICAL	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	87LGHINSTRUMENT, CAST REMOVAL, AC-POWERED	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	79GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	80KYWCONTAINER, LIQUID MEDICATION, GRADUATED	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	90IXCILLUMINATOR, RADIOGRAPHIC-FILM	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	80FNPURINAL	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	83LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)
6/25/2004	74LDESTETHOSCOPE, MANUAL	476NO REGISTR 508NO 510(K)	Florida District Office (FLA-DO)

Frequently Asked Questions

What is M.d. International, Inc.'s FDA import refusal history?

M.d. International, Inc. (FEI: 1000114102) has 14 FDA import refusal record(s) in our database, spanning from 6/25/2004 to 6/25/2004.

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. M.d. International, Inc.'s FEI number is 1000114102.

What types of violations has M.d. International, Inc. received?

M.d. International, 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 M.d. International, Inc. come from?

All FDA import refusal data for M.d. International, 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.