Church & Dwight Ltd
⚠️ Moderate Risk
FEI: 3004415710 • Mississauga, ON • CANADA
FEI Number
3004415710
Location
Mississauga, ON
Country
CANADAAddress
6600 Kitimat Rd, , Mississauga, ON, 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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/29/2006 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 8/25/2006 | 80KZHINTRODUCER, SYRINGE NEEDLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/25/2006 | 61TIB06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/24/2005 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) | |
| 5/24/2005 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Church & Dwight Ltd's FDA import refusal history?
Church & Dwight Ltd (FEI: 3004415710) has 5 FDA import refusal record(s) in our database, spanning from 5/24/2005 to 8/29/2006.
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 Ltd's FEI number is 3004415710.
What types of violations has Church & Dwight Ltd received?
Church & Dwight Ltd 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 Church & Dwight Ltd come from?
All FDA import refusal data for Church & Dwight Ltd 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.