Church & Dwight UK Limited
⚠️ High Risk
FEI: 3004983145 • Folkestone, Kent • UNITED KINGDOM
FEI Number
3004983145
Location
Folkestone, Kent
Country
UNITED KINGDOMAddress
Premier House, Shearway Business Park; Pent Road, Folkestone, Kent, United Kingdom
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).
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/17/2025 | 62WBY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Northeast Imports (DNEI) | |
| 4/28/2025 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2025 | 66VBM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/23/2025 | 66VBM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/23/2025 | 66VBM99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/22/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 62WBY09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 1/22/2025 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 1/22/2025 | 64LBM38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 1/22/2025 | 64LBM38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 10/17/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/21/2023 | 62WIM09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 9/15/2023 | 62WAY11BISMUTH SUBGALLATE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 6/12/2023 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 6/12/2023 | 63RCY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 5/22/2023 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 5/15/2023 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 5/12/2023 | 64DBK99EMOLLIENT, LUBRICANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/17/2023 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 4/20/2022 | 62WBJ09ZINC OXIDE ASTRINGENT/ANTI-PERSPIRANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/20/2020 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 4/20/2012 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Church & Dwight UK Limited's FDA import refusal history?
Church & Dwight UK Limited (FEI: 3004983145) has 23 FDA import refusal record(s) in our database, spanning from 4/20/2012 to 7/17/2025.
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 UK Limited's FEI number is 3004983145.
What types of violations has Church & Dwight UK Limited received?
Church & Dwight UK Limited has been cited for 8 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 UK Limited come from?
All FDA import refusal data for Church & Dwight UK Limited 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.