Church & Dwight Inc
⚠️ Moderate Risk
FEI: 2280705 • Princeton, NJ • UNITED STATES
FEI Number
2280705
Location
Princeton, NJ
Country
UNITED STATESAddress
469 N Harrison St, , Princeton, NJ, United States
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).
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.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/13/2021 | 62WBL05ZIRCONIUM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/13/2021 | 62WBL05ZIRCONIUM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/13/2021 | 62WBL05ZIRCONIUM | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/24/2020 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 5/24/2020 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 8/10/2018 | 85LTZCONDOM WITH NONOXYNOL-9 | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/6/2009 | 85HISCONDOM | New Orleans District Office (NOL-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Church & Dwight Inc's FDA import refusal history?
Church & Dwight Inc (FEI: 2280705) has 9 FDA import refusal record(s) in our database, spanning from 11/29/2005 to 3/13/2021.
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. Church & Dwight Inc's FEI number is 2280705.
What types of violations has Church & Dwight Inc received?
Church & Dwight Inc has been cited for 6 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 Inc come from?
All FDA import refusal data for Church & Dwight 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.