Tomofuji Shoji Co., Ltd
⚠️ Moderate Risk
FEI: 3005219041 • Kobe, Hyogo • JAPAN
FEI Number
3005219041
Location
Kobe, Hyogo
Country
JAPANAddress
1 Chome 14-21, Ninomiya-Machi; Chuo, 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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
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.
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 |
|---|---|---|---|
| 8/4/2011 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/12/2011 | 89IMDPACK, HOT OR COLD, DISPOSABLE | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 7/12/2011 | 89IMDPACK, HOT OR COLD, DISPOSABLE | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 4/22/2011 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | San Francisco District Office (SAN-DO) | |
| 4/22/2011 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 197COSM COLOR | San Francisco District Office (SAN-DO) |
| 4/22/2011 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 197COSM COLOR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Tomofuji Shoji Co., Ltd's FDA import refusal history?
Tomofuji Shoji Co., Ltd (FEI: 3005219041) has 6 FDA import refusal record(s) in our database, spanning from 4/22/2011 to 8/4/2011.
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. Tomofuji Shoji Co., Ltd's FEI number is 3005219041.
What types of violations has Tomofuji Shoji Co., Ltd received?
Tomofuji Shoji Co., Ltd 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 Tomofuji Shoji Co., Ltd come from?
All FDA import refusal data for Tomofuji Shoji Co., Ltd 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.