Church & Dwight Canada
⚠️ Moderate Risk
FEI: 3006667835 • Mississauga, ONTARIO • CANADA
FEI Number
3006667835
Location
Mississauga, ONTARIO
Country
CANADAAddress
635 Secretariat Court, , 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).
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/17/2024 | 60QBJ69PRAMOXINE HCL (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 1/17/2023 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 6/15/2022 | 60QBM69PRAMOXINE HCL (ANESTHETIC) | Division of Northern Border Imports (DNBI) | |
| 11/30/2020 | 60SAY99ANTACID, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/18/2018 | 60QBM69PRAMOXINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/18/2018 | 61TBB06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/27/2017 | 60LBJ99ANALGESIC, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/24/2014 | 85HISCONDOM | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/5/2011 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 1/4/2011 | 61TCA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/28/2009 | 55RP99PHARMACEUTIC NECESSITIES, N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Church & Dwight Canada's FDA import refusal history?
Church & Dwight Canada (FEI: 3006667835) has 11 FDA import refusal record(s) in our database, spanning from 9/28/2009 to 9/17/2024.
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. Church & Dwight Canada's FEI number is 3006667835.
What types of violations has Church & Dwight Canada received?
Church & Dwight Canada 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 Church & Dwight Canada come from?
All FDA import refusal data for Church & Dwight Canada 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.