Medivet Pty Ltd
⚠️ Moderate Risk
FEI: 3009383893 • Yagoona, New South Wales • AUSTRALIA
FEI Number
3009383893
Location
Yagoona, New South Wales
Country
AUSTRALIAAddress
U A4 101 Rookwood Rd, , Yagoona, New South Wales, 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
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.
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/9/2012 | 68YYX20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | San Francisco District Office (SAN-DO) |
| 9/23/2010 | 64HRY99EXPECTORANT N.E.C. | Cincinnati District Office (CIN-DO) | |
| 9/23/2010 | 53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | Cincinnati District Office (CIN-DO) | |
| 9/23/2010 | 68KBL20WOUND DRESSING USED MORE THAN 1 SPECIES | Cincinnati District Office (CIN-DO) | |
| 9/23/2010 | 68YYK20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | Cincinnati District Office (CIN-DO) | |
| 6/14/2010 | 68KAQ20WOUND DRESSING USED MORE THAN 1 SPECIES | Cincinnati District Office (CIN-DO) | |
| 6/14/2010 | 68GAL20NUTRIENT USED MORE THAN 1 SPECIES | Cincinnati District Office (CIN-DO) | |
| 6/14/2010 | 68IAK20TONIC USED MORE THAN 1 SPECIES | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Medivet Pty Ltd's FDA import refusal history?
Medivet Pty Ltd (FEI: 3009383893) has 8 FDA import refusal record(s) in our database, spanning from 6/14/2010 to 4/9/2012.
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. Medivet Pty Ltd's FEI number is 3009383893.
What types of violations has Medivet Pty Ltd received?
Medivet Pty Ltd has been cited for 3 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 Medivet Pty Ltd come from?
All FDA import refusal data for Medivet Pty Ltd 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.