Colgate-Palmolive China
⚠️ High Risk
FEI: 3004124961 • Guangzhou, Guangdong • CHINA
FEI Number
3004124961
Location
Guangzhou, Guangdong
Country
CHINAAddress
338 Qingnian Road Xin Gang Huangpu, Getdd, , Guangzhou, Guangdong, China
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
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).
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.
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/31/2025 | 63RCY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 9/12/2025 | 63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 4/3/2025 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Northeast Imports (DNEI) | |
| 4/3/2025 | 63RBG06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 8/27/2024 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Northeast Imports (DNEI) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 7/10/2012 | 63RAY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | New York District Office (NYK-DO) | |
| 8/6/2007 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 8/6/2007 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 6/12/2006 | 63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Colgate-Palmolive China's FDA import refusal history?
Colgate-Palmolive China (FEI: 3004124961) has 16 FDA import refusal record(s) in our database, spanning from 6/12/2006 to 10/31/2025.
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. Colgate-Palmolive China's FEI number is 3004124961.
What types of violations has Colgate-Palmolive China received?
Colgate-Palmolive China 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 Colgate-Palmolive China come from?
All FDA import refusal data for Colgate-Palmolive China 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.