Bausch Health Companies Inc.
⚠️ High Risk
FEI: 3002807186 • Laval, Quebec • CANADA
FEI Number
3002807186
Location
Laval, Quebec
Country
CANADAAddress
2150 Saint-Elzear Blvd W, , Laval, Quebec, 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).
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).
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
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.
FORBIDDEN
The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 64BDB14CHLORTHALIDONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/21/2025 | 60LBA99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/17/2025 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2025 | 61ECL01CROMOLYN SODIUM (ANTI-ASTHMATIC) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 61FCY63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | Division of Southeast Imports (DSEI) | |
| 3/28/2023 | 61PCY17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/6/2023 | 62OCB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2020 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2020 | 63BCQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/15/2019 | 62OCY24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2019 | 62OCB24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2017 | 66MCA86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2016 | 54ACY99VITAMIN, N.E.C. | Cincinnati District Office (CIN-DO) | |
| 10/19/2016 | 54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 10/3/2016 | 64LCQ02BECLOMETHASONE DIPROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/21/2016 | 61PDK17INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/9/2011 | 62OCA37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/7/2011 | 63HAM01BISACODYL (CATHARTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/7/2011 | 63EAB19AMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2010 | 62ODB05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/5/2010 | 61PBP26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/4/2010 | 64XDK03BENZOYL PEROXIDE (KERATOLYTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/14/2010 | 61EBB06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/19/2009 | 61PIK17INSULIN (INJ) (ANTI-DIABETIC) | New Orleans District Office (NOL-DO) | |
| 3/30/2009 | 62OCE05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/25/2006 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/26/2006 | 63ACA07RISEDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/31/2006 | 61XBB41ACRIVASTINE/PSEUDOEPHEDRINE HCL (ANTI-HISTAMINIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/22/2005 | 60CAC10PSEUDOEPHEDRINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 9/1/2005 | 61XBB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 9/1/2005 | 61XBB08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 6/28/2005 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/22/2005 | 60CBA10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/22/2005 | 60CBA10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/4/2005 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/3/2005 | 61XCY99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/26/2004 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | Detroit District Office (DET-DO) | |
| 2/25/2004 | 61EAA06FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2003 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/13/2002 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/20/2001 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Bausch Health Companies Inc.'s FDA import refusal history?
Bausch Health Companies Inc. (FEI: 3002807186) has 41 FDA import refusal record(s) in our database, spanning from 11/20/2001 to 12/1/2025.
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. Bausch Health Companies Inc.'s FEI number is 3002807186.
What types of violations has Bausch Health Companies Inc. received?
Bausch Health Companies Inc. has been cited for 9 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 Bausch Health Companies Inc. come from?
All FDA import refusal data for Bausch Health Companies Inc. 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.