Bausch Health Companies Inc.
⚠️ High Risk
FEI: 3002806613 • Steinbach, Manitoba • CANADA
FEI Number
3002806613
Location
Steinbach, Manitoba
Country
CANADAAddress
100 Life Sciences Pky, Box 21390, Steinbach, Manitoba, 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/7/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2022 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/13/2018 | 61NCB05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2017 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2015 | 66VBF99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/17/2005 | 62VDO18ACYCLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/17/2002 | 60LIC69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/19/2001 | 55RP14HYDROXYPROPYL METHYLCELLULOSE (PHARMACEUTIC NECESSITY - SUSPENDING AGENT) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 11/1/2001 | 66VIE99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | 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: 3002806613) has 9 FDA import refusal record(s) in our database, spanning from 11/1/2001 to 2/7/2023.
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 3002806613.
What types of violations has Bausch Health Companies Inc. received?
Bausch Health Companies Inc. has been cited for 2 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.