P&G
⚠️ Moderate Risk
FEI: 3001300102 • Kobe • 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/29/2012 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/19/2010 | 53GC02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 8/19/2010 | 53GD02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is P&G's FDA import refusal history?
P&G (FEI: 3001300102) has 3 FDA import refusal record(s) in our database, spanning from 8/19/2010 to 2/29/2012.
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's FEI number is 3001300102.
What types of violations has P&G received?
P&G has been cited for 2 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 come from?
All FDA import refusal data for P&G 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.