Arakaki Tsusho
⚠️ Moderate Risk
FEI: 3004835908 • Okinawa • 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/15/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 3/15/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 198COLOR LBLG | New York District Office (NYK-DO) |
| 3/15/2010 | 53GB05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53GB05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53GB05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53GB05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53GB05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53GB05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | New York District Office (NYK-DO) | |
| 3/15/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) | |
| 3/15/2010 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Arakaki Tsusho's FDA import refusal history?
Arakaki Tsusho (FEI: 3004835908) has 11 FDA import refusal record(s) in our database, spanning from 3/15/2010 to 3/15/2010.
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. Arakaki Tsusho's FEI number is 3004835908.
What types of violations has Arakaki Tsusho received?
Arakaki Tsusho has been cited for 4 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 Arakaki Tsusho come from?
All FDA import refusal data for Arakaki Tsusho 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.