Buckley'S Company
⚠️ Moderate Risk
FEI: 3012052737 • Mississauga, Ontario • CANADA
FEI Number
3012052737
Location
Mississauga, Ontario
Country
CANADAAddress
154 Church St, , 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.
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 |
|---|---|---|---|
| 7/20/2021 | 66HBL06CYCLAMATE SODIUM (SWEETENER) | Division of Northern Border Imports (DNBI) | |
| 6/14/2016 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 60LBA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 64HBL02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 64HBL02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 62MBL08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 61XBL18DIPHENHYDRAMINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 62UBL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 5/24/2016 | 61XBK08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 5/24/2016 | 61XBK08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 5/24/2016 | 61XBK08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | New York District Office (NYK-DO) | |
| 5/24/2016 | 60LBH01ACETAMINOPHEN (ANALGESIC) | New York District Office (NYK-DO) | |
| 5/4/2016 | 62UDK11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/4/2016 | 62UDA11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/4/2016 | 62UDK11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Detroit District Office (DET-DO) |
| 5/4/2016 | 62UDK11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Buckley'S Company's FDA import refusal history?
Buckley'S Company (FEI: 3012052737) has 17 FDA import refusal record(s) in our database, spanning from 5/4/2016 to 7/20/2021.
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. Buckley'S Company's FEI number is 3012052737.
What types of violations has Buckley'S Company received?
Buckley'S 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 Buckley'S Company come from?
All FDA import refusal data for Buckley'S 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.