Bayer Australia Ltd.
⚠️ High Risk
FEI: 1000436007 • Pymble, New South Wales • AUSTRALIA
FEI Number
1000436007
Location
Pymble, New South Wales
Country
AUSTRALIAAddress
875 Pacific Hwy, , Pymble, New South Wales, Australia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
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.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
VET LEGEND
The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/12/2024 | 63NBJ04DEXPANTHENOL (CHOLINERGIC) | Division of West Coast Imports (DWCI) | |
| 6/12/2024 | 63NAY04DEXPANTHENOL (CHOLINERGIC) | Division of West Coast Imports (DWCI) | |
| 8/3/2020 | 54AGH13VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 54AGB12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2019 | 64GDY19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/2/2016 | 63NBO04DEXPANTHENOL (CHOLINERGIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/19/2014 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 8/15/2003 | 68HAJ10SMALL ANIMAL PARASITICIDES (EXTERNAL) | 343VET LEGEND | New Orleans District Office (NOL-DO) |
| 11/12/2001 | 61FDB55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bayer Australia Ltd.'s FDA import refusal history?
Bayer Australia Ltd. (FEI: 1000436007) has 9 FDA import refusal record(s) in our database, spanning from 11/12/2001 to 6/12/2024.
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. Bayer Australia Ltd.'s FEI number is 1000436007.
What types of violations has Bayer Australia Ltd. received?
Bayer Australia Ltd. has been cited for 5 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 Bayer Australia Ltd. come from?
All FDA import refusal data for Bayer Australia 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.