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Medical Developements

⚠️ Moderate Risk

FEI: 3003751772 • Springvale, VIC • AUSTRALIA

FEI

FEI Number

3003751772

📍

Location

Springvale, VIC

🇦🇺

Country

AUSTRALIA
🏢

Address

Gen Delivery, , Springvale, VIC, Australia

Moderate Risk

FDA Import Risk Assessment

38.9
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
1/3/2011
Latest Refusal
5/23/2003
Earliest Refusal

Score Breakdown

Violation Severity
74.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
6.6×10%
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

724×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

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).

Refusal History

DateProductViolationsDivision
1/3/2011
60QIY15METHOXYFLURANE (ANESTHETIC)
118NOT LISTED
New Orleans District Office (NOL-DO)
2/6/2004
60QSK15METHOXYFLURANE (ANESTHETIC)
72NEW VET DR
Minneapolis District Office (MIN-DO)
5/23/2003
68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
72NEW VET DR
Minneapolis District Office (MIN-DO)
5/23/2003
68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
72NEW VET DR
Minneapolis District Office (MIN-DO)
5/23/2003
68YYY20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
72NEW VET DR
Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Medical Developements's FDA import refusal history?

Medical Developements (FEI: 3003751772) has 5 FDA import refusal record(s) in our database, spanning from 5/23/2003 to 1/3/2011.

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. Medical Developements's FEI number is 3003751772.

What types of violations has Medical Developements received?

Medical Developements 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 Medical Developements come from?

All FDA import refusal data for Medical Developements 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.