Par Church & Dwight Canada Corp
⚠️ Moderate Risk
FEI: 3012322892 • Mississauga, Ontario • CANADA
FEI Number
3012322892
Location
Mississauga, Ontario
Country
CANADAAddress
Unknown, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/19/2019 | 60QBM69PRAMOXINE HCL (ANESTHETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/14/2016 | 61VAL01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 61TAY99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 61TAA99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 61TAA06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 6/14/2016 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Par Church & Dwight Canada Corp's FDA import refusal history?
Par Church & Dwight Canada Corp (FEI: 3012322892) has 6 FDA import refusal record(s) in our database, spanning from 6/14/2016 to 6/19/2019.
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. Par Church & Dwight Canada Corp's FEI number is 3012322892.
What types of violations has Par Church & Dwight Canada Corp received?
Par Church & Dwight Canada Corp has been cited for 1 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 Par Church & Dwight Canada Corp come from?
All FDA import refusal data for Par Church & Dwight Canada Corp 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.