Ceva Animal Health Pty Ltd
⚠️ Moderate Risk
FEI: 3008975242 • Glenorie, New South Wales • AUSTRALIA
FEI Number
3008975242
Location
Glenorie, New South Wales
Country
AUSTRALIAAddress
11 Moores Rd, , Glenorie, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2016 | 68XCK02HORSES DEVICE/DIAG PROD FOR ANIMAL | Atlanta District Office (ATL-DO) | |
| 9/24/2015 | 68YCY04SHEEP ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 10/6/2014 | 68YDY02HORSES ANIMAL DRUGS N.E.C. | Detroit District Office (DET-DO) | |
| 5/29/2012 | 60KRY06ETHYLESTRENOL (ANABOLIC) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 9/30/2011 | 62KAY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 7/17/2003 | 66QLY10PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ceva Animal Health Pty Ltd's FDA import refusal history?
Ceva Animal Health Pty Ltd (FEI: 3008975242) has 6 FDA import refusal record(s) in our database, spanning from 7/17/2003 to 3/10/2016.
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. Ceva Animal Health Pty Ltd's FEI number is 3008975242.
What types of violations has Ceva Animal Health Pty Ltd received?
Ceva Animal Health Pty Ltd 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 Ceva Animal Health Pty Ltd come from?
All FDA import refusal data for Ceva Animal Health 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.