Baxter Corporation
⚠️ High Risk
FEI: 3009146219 • Mississauga, Ontario • CANADA
FEI Number
3009146219
Location
Mississauga, Ontario
Country
CANADAAddress
7125 Mississauga Rd, , Mississauga, 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
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).
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.
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).
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.
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
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 |
|---|---|---|---|
| 3/4/2025 | 65RBY12POTASSIC SALINE (INJECTION) (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2025 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2025 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/15/2025 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 1/2/2025 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of West Coast Imports (DWCI) | |
| 12/11/2024 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 342PERSONALRX | Division of West Coast Imports (DWCI) |
| 12/11/2024 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 342PERSONALRX | Division of West Coast Imports (DWCI) |
| 12/9/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of West Coast Imports (DWCI) | |
| 12/9/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of West Coast Imports (DWCI) | |
| 12/4/2024 | 65RBL19SODIUM CHLORIDE (REPLENISHER) | Division of West Coast Imports (DWCI) | |
| 12/2/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of West Coast Imports (DWCI) | |
| 12/2/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of West Coast Imports (DWCI) | |
| 11/26/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of West Coast Imports (DWCI) | |
| 11/25/2024 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 11/25/2024 | 65RCK19SODIUM CHLORIDE (REPLENISHER) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 11/21/2024 | 64ZDK01CALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS | Division of Northern Border Imports (DNBI) | |
| 11/15/2024 | 65RDK19SODIUM CHLORIDE (REPLENISHER) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 65FCK03WATER, FOR INJECTION, U.S.P. (PHARMACEUTIC AID) | 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) | |
| 9/10/2020 | 62IDI15CYCLOPHOSPHAMIDE (ANTI-NEOPLASTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/5/2019 | 62IIA15CYCLOPHOSPHAMIDE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/15/2018 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | Division of Southeast Imports (DSEI) | |
| 10/31/2014 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Baxter Corporation's FDA import refusal history?
Baxter Corporation (FEI: 3009146219) has 28 FDA import refusal record(s) in our database, spanning from 10/31/2014 to 3/4/2025.
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 3009146219.
What types of violations has Baxter Corporation received?
Baxter Corporation has been cited for 7 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.