MSH Pharma Inc.
⚠️ High Risk
FEI: 3003082936 • Mont-Saint-Hilaire, Quebec • CANADA
FEI Number
3003082936
Location
Mont-Saint-Hilaire, Quebec
Country
CANADAAddress
597 Sir-Wilfrid-Laurier Blvd, , Mont-Saint-Hilaire, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2025 | 66CBL99STOOL SOFTENER N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 66CBM99STOOL SOFTENER N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 66CBM99STOOL SOFTENER N.E.C. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 60CBM09PHENYLEPHRINE HCL (ADRENERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 60CBM09PHENYLEPHRINE HCL (ADRENERGIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 63HAM01BISACODYL (CATHARTIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 63HAM01BISACODYL (CATHARTIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 63HAM01BISACODYL (CATHARTIC) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/13/2007 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/31/2002 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is MSH Pharma Inc.'s FDA import refusal history?
MSH Pharma Inc. (FEI: 3003082936) has 10 FDA import refusal record(s) in our database, spanning from 1/31/2002 to 8/13/2025.
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. MSH Pharma Inc.'s FEI number is 3003082936.
What types of violations has MSH Pharma Inc. received?
MSH Pharma 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 MSH Pharma Inc. come from?
All FDA import refusal data for MSH Pharma 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.