Church & Dwight Co., Inc.
⚠️ High Risk
FEI: 3014967081 • Ewing, NJ • UNITED STATES
FEI Number
3014967081
Location
Ewing, NJ
Country
UNITED STATESAddress
500 Charles Ewing Blvd, , Ewing, NJ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
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).
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.
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.
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 |
|---|---|---|---|
| 9/25/2025 | 63RDG04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 1/16/2024 | 62MBO01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2023 | 76EFSUNIT, ORAL IRRIGATION | Division of Southeast Imports (DSEI) | |
| 8/26/2022 | 85HISCONDOM | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 10/1/2019 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 10/1/2019 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/24/2019 | 66YAL99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/13/2019 | 60QBJ56BENZOCAINE (ANESTHETIC) | Division of Northeast Imports (DNEI) | |
| 1/23/2019 | 64RCY22SOMATROPIN (RDNA ORIGIN) (HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Church & Dwight Co., Inc.'s FDA import refusal history?
Church & Dwight Co., Inc. (FEI: 3014967081) has 9 FDA import refusal record(s) in our database, spanning from 1/23/2019 to 9/25/2025.
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 Co., Inc.'s FEI number is 3014967081.
What types of violations has Church & Dwight Co., Inc. received?
Church & Dwight Co., 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 Co., Inc. come from?
All FDA import refusal data for Church & Dwight Co., 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.