Sanwa Jp
⚠️ Moderate Risk
FEI: 3011421585 • Inazawa-Shi, Aichi • JAPAN
FEI Number
3011421585
Location
Inazawa-Shi, Aichi
Country
JAPANAddress
Aza 11-19 Wa-Shi, Nagano, Inazawa-Shi, Aichi, 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)
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2015 | 53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 5/5/2015 | 80LLKNON-INFLATABLE COMPRESSION LEGGING | Cincinnati District Office (CIN-DO) | |
| 5/5/2015 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Sanwa Jp's FDA import refusal history?
Sanwa Jp (FEI: 3011421585) has 3 FDA import refusal record(s) in our database, spanning from 5/5/2015 to 5/5/2015.
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. Sanwa Jp's FEI number is 3011421585.
What types of violations has Sanwa Jp received?
Sanwa Jp 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 Sanwa Jp come from?
All FDA import refusal data for Sanwa Jp 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.