P&G K.K.
⚠️ Moderate Risk
FEI: 1000384168 • Yasu, Shiga • JAPAN
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
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2014 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/24/2014 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 3/4/2013 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Southeast Imports (DSEI) |
| 5/7/2010 | 65LAJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 2/5/2009 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 2/5/2009 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 4/6/2004 | 66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is P&G K.K.'s FDA import refusal history?
P&G K.K. (FEI: 1000384168) has 20 FDA import refusal record(s) in our database, spanning from 4/6/2004 to 6/24/2014.
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. P&G K.K.'s FEI number is 1000384168.
What types of violations has P&G K.K. received?
P&G K.K. 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 P&G K.K. come from?
All FDA import refusal data for P&G K.K. 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.