Baxter Laboratories Pty. Ltd.
⚠️ Moderate Risk
FEI: 3003945201 • Boronia, Victoria • AUSTRALIA
FEI Number
3003945201
Location
Boronia, Victoria
Country
AUSTRALIAAddress
1019 Mountain Hwy, , Boronia, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2015 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Southwest Import District Office (SWI-DO) | |
| 5/29/2014 | 53GY03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/29/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/29/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/8/2014 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Baxter Laboratories Pty. Ltd.'s FDA import refusal history?
Baxter Laboratories Pty. Ltd. (FEI: 3003945201) has 5 FDA import refusal record(s) in our database, spanning from 5/8/2014 to 10/21/2015.
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. Baxter Laboratories Pty. Ltd.'s FEI number is 3003945201.
What types of violations has Baxter Laboratories Pty. Ltd. received?
Baxter Laboratories Pty. Ltd. 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 Baxter Laboratories Pty. Ltd. come from?
All FDA import refusal data for Baxter Laboratories 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.