Buckleys Inc
⚠️ Moderate Risk
FEI: 3004769669 • Mississauga, ONTARIO • CANADA
FEI Number
3004769669
Location
Mississauga, ONTARIO
Country
CANADAAddress
2233 Argentia Rd /#205 On, , 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
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).
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.
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2022 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 6/2/2010 | 55QY68AMMONIUM CARBONATE (PHARMACEUTIC NECESSITY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/11/2006 | 62UBL99ANTI-TUSSIVE/COLD N.E.C. | 331DR QUALITC | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Buckleys Inc's FDA import refusal history?
Buckleys Inc (FEI: 3004769669) has 3 FDA import refusal record(s) in our database, spanning from 7/11/2006 to 12/9/2022.
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 Inc's FEI number is 3004769669.
What types of violations has Buckleys Inc received?
Buckleys Inc 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 Inc come from?
All FDA import refusal data for Buckleys 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.