Church & Dwight Manufacturing Co., Ltd.
⚠️ High Risk
FEI: 1122329 • South Chesterfield, VA • UNITED STATES
FEI Number
1122329
Location
South Chesterfield, VA
Country
UNITED STATESAddress
1851 Touchstone Rd, , South Chesterfield, VA, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85LTZCONDOM WITH NONOXYNOL-9 | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85LTZCONDOM WITH NONOXYNOL-9 | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 3/6/2007 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-DO) | |
| 11/29/2005 | 85HISCONDOM | New York District Office (NYK-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 Manufacturing Co., Ltd.'s FDA import refusal history?
Church & Dwight Manufacturing Co., Ltd. (FEI: 1122329) has 39 FDA import refusal record(s) in our database, spanning from 11/29/2005 to 3/6/2007.
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 Manufacturing Co., Ltd.'s FEI number is 1122329.
What types of violations has Church & Dwight Manufacturing Co., Ltd. received?
Church & Dwight Manufacturing Co., Ltd. has been cited for 3 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 Manufacturing Co., Ltd. come from?
All FDA import refusal data for Church & Dwight Manufacturing Co., 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.