Procter & Gamble Far East, Inc.
⚠️ Moderate Risk
FEI: 1000174735 • Kobe, Hyogo • JAPAN
FEI Number
1000174735
Location
Kobe, Hyogo
Country
JAPANAddress
17, Koyochonaka; Higashinada, Kobe, Hyogo, 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
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
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).
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 |
|---|---|---|---|
| 8/7/2006 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | New York District Office (NYK-DO) | |
| 4/23/2003 | 70MY20MIXED FEED RATION USED FOR MORE THAN ONE SPECIES | 308MFR INSAN | Cincinnati District Office (CIN-DO) |
| 4/23/2003 | 70MY20MIXED FEED RATION USED FOR MORE THAN ONE SPECIES | 308MFR INSAN | Cincinnati District Office (CIN-DO) |
| 4/23/2003 | 70MY20MIXED FEED RATION USED FOR MORE THAN ONE SPECIES | 308MFR INSAN | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Procter & Gamble Far East, Inc.'s FDA import refusal history?
Procter & Gamble Far East, Inc. (FEI: 1000174735) has 4 FDA import refusal record(s) in our database, spanning from 4/23/2003 to 8/7/2006.
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. Procter & Gamble Far East, Inc.'s FEI number is 1000174735.
What types of violations has Procter & Gamble Far East, Inc. received?
Procter & Gamble Far East, Inc. 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 Procter & Gamble Far East, Inc. come from?
All FDA import refusal data for Procter & Gamble Far East, 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.