BUCKLEYS COMPANY
⚠️ Moderate Risk
FEI: 3013221928 • Mississauga, Ontario • CANADA
FEI Number
3013221928
Location
Mississauga, Ontario
Country
CANADAAddress
7125 Mississauga Rd Suite, , Mississauga, Ontario, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/13/2024 | 66FDK99SUPPRESSANT N.E.C. | Division of Northern Border Imports (DNBI) | |
| 11/7/2023 | 62UAY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | Division of West Coast Imports (DWCI) | |
| 1/4/2021 | 60LDA01ACETAMINOPHEN (ANALGESIC) | Division of Northern Border Imports (DNBI) | |
| 7/8/2020 | 62UDL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2020 | 62UAY99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/6/2019 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BUCKLEYS COMPANY's FDA import refusal history?
BUCKLEYS COMPANY (FEI: 3013221928) has 6 FDA import refusal record(s) in our database, spanning from 6/6/2019 to 11/13/2024.
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. BUCKLEYS COMPANY's FEI number is 3013221928.
What types of violations has BUCKLEYS COMPANY received?
BUCKLEYS COMPANY has been cited for 4 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 BUCKLEYS COMPANY come from?
All FDA import refusal data for BUCKLEYS COMPANY 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.