Brands International Corporation
⚠️ High Risk
FEI: 3007389902 • Newmarket, Ontario • CANADA
FEI Number
3007389902
Location
Newmarket, Ontario
Country
CANADAAddress
594 Newpark Blvd, , Newmarket, 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
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).
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/11/2025 | 66GBJ25DIMETHICONE 350 (SURGICAL/PROSTHETIC AID) | Division of Northern Border Imports (DNBI) | |
| 11/13/2024 | 60BAL99ACIDIFIER N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 11/13/2024 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 9/18/2023 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/24/2023 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 3/24/2023 | 62HAL99ANTI-MICROBIAL N.E.C. | 178COL ADDED | Division of Northern Border Imports (DNBI) |
| 3/25/2022 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/8/2021 | 63HAL05CASANTHRANOL (CATHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2020 | 61HBL99ANTI-BACTERIAL, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 5/11/2020 | 62HAL99ANTI-MICROBIAL N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/13/2016 | 64AAL20TRICLOSAN (DISINFECTANT) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 7/13/2016 | 64AAL20TRICLOSAN (DISINFECTANT) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 4/18/2016 | 64ABL20TRICLOSAN (DISINFECTANT) | New York District Office (NYK-DO) | |
| 8/13/2012 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Brands International Corporation's FDA import refusal history?
Brands International Corporation (FEI: 3007389902) has 22 FDA import refusal record(s) in our database, spanning from 8/13/2012 to 12/11/2025.
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. Brands International Corporation's FEI number is 3007389902.
What types of violations has Brands International Corporation received?
Brands International 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 Brands International Corporation come from?
All FDA import refusal data for Brands International 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.