MEDICAL DEVELOPMENTS INTERNATIONAL
⚠️ Moderate Risk
FEI: 3005977696 • Scoresby, Victoria • AUSTRALIA
FEI Number
3005977696
Location
Scoresby, Victoria
Country
AUSTRALIAAddress
4 Caribbean Dr, , Scoresby, Victoria, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2021 | 60QDQ15METHOXYFLURANE (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 5/6/2005 | 64TIL08TACROLIMUS (IMMUNOSUPPRESSIVE) | 72NEW VET DR | Minneapolis District Office (MIN-DO) |
| 6/18/2004 | 60QIY99ANESTHETIC, N.E.C. | New York District Office (NYK-DO) | |
| 1/3/2002 | 68YAK10SMALL ANIMAL ANIMAL DRUGS N.E.C. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is MEDICAL DEVELOPMENTS INTERNATIONAL's FDA import refusal history?
MEDICAL DEVELOPMENTS INTERNATIONAL (FEI: 3005977696) has 4 FDA import refusal record(s) in our database, spanning from 1/3/2002 to 7/12/2021.
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 DEVELOPMENTS INTERNATIONAL's FEI number is 3005977696.
What types of violations has MEDICAL DEVELOPMENTS INTERNATIONAL received?
MEDICAL DEVELOPMENTS INTERNATIONAL has been cited for 4 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 DEVELOPMENTS INTERNATIONAL come from?
All FDA import refusal data for MEDICAL DEVELOPMENTS INTERNATIONAL 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.