Baxter Corporation
⚠️ High Risk
FEI: 3002891260 • Alliston, Ontario • CANADA
FEI Number
3002891260
Location
Alliston, Ontario
Country
CANADAAddress
89 Centre St S, , Alliston, Ontario, Canada
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
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.
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).
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.
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 |
|---|---|---|---|
| 2/21/2025 | 65CDN99NUTRIENT/TONIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 1/6/2025 | 65RDK17RINGER'S INJECTION, LACTATED (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/26/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 12/19/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 12/19/2024 | 65RBL19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 12/19/2024 | 65RBL19SODIUM CHLORIDE (REPLENISHER) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 12/11/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 12/11/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/11/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/11/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/11/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/11/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 12/11/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/20/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/20/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/20/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/20/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/20/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/20/2024 | 65RAK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK04WATER (PHARM AID) FOR INJ, STERILE, U.S.P. | Division of Northern Border Imports (DNBI) | |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/12/2024 | 65RCN99REPLENISHER N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/20/2024 | 65RDA14POTASSIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2022 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 64WBK99IRRIGATION SOLUTION N.E.C. | New York District Office (NYK-DO) | |
| 10/16/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Baxter Corporation's FDA import refusal history?
Baxter Corporation (FEI: 3002891260) has 27 FDA import refusal record(s) in our database, spanning from 10/16/2008 to 2/21/2025.
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 Corporation's FEI number is 3002891260.
What types of violations has Baxter Corporation received?
Baxter Corporation has been cited for 6 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 Corporation come from?
All FDA import refusal data for Baxter Corporation 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.