Peptech Animal Health Pty Ltd.
⚠️ Moderate Risk
FEI: 3002886659 • Sydney, New South Wales • AUSTRALIA
FEI Number
3002886659
Location
Sydney, New South Wales
Country
AUSTRALIAAddress
19-25 Khartoum Rd, Macquarie Park, , Sydney, 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).
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 |
|---|---|---|---|
| 4/25/2019 | 64MQY99GONAD-STIMULATING PRINCIPLE N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 2/23/2015 | 64GRY99ESTROGEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/22/2014 | 68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 12/20/2012 | 64RKK99HORMONE N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 11/14/2012 | 68FCB20HORMONES USED MORE THAN 1 SPECIES | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
| 10/29/2012 | 64RKK99HORMONE N.E.C. | 72NEW VET DR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Peptech Animal Health Pty Ltd.'s FDA import refusal history?
Peptech Animal Health Pty Ltd. (FEI: 3002886659) has 6 FDA import refusal record(s) in our database, spanning from 10/29/2012 to 4/25/2019.
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. Peptech Animal Health Pty Ltd.'s FEI number is 3002886659.
What types of violations has Peptech Animal Health Pty Ltd. received?
Peptech Animal Health 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 Peptech Animal Health Pty Ltd. come from?
All FDA import refusal data for Peptech 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.