Church & Dwight Co., Inc.
⚠️ Moderate Risk
FEI: 2224549 • Lakewood, NJ • UNITED STATES
FEI Number
2224549
Location
Lakewood, NJ
Country
UNITED STATESAddress
800 Airport Rd, , Lakewood, 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
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.
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 7/16/2021 | 75LCXKIT, TEST, PREGNANCY, HCG, OVER THE COUNTER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 11/28/2005 | 53LG02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 11/28/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WBL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 11/28/2005 | 62WAQ99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Church & Dwight Co., Inc.'s FDA import refusal history?
Church & Dwight Co., Inc. (FEI: 2224549) has 47 FDA import refusal record(s) in our database, spanning from 11/28/2005 to 7/16/2021.
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 Co., Inc.'s FEI number is 2224549.
What types of violations has Church & Dwight Co., Inc. received?
Church & Dwight Co., Inc. has been cited for 5 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.