Sanmi Co., Ltd.
⚠️ Moderate Risk
FEI: 3000140888 • Aichi • JAPAN
FEI Number
3000140888
Location
Aichi
Country
JAPANAddress
26 Nakamura Cho, Handa 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2003 | 27VCP99VINEGAR, N.E.C. | 83NO PROCESS | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Sanmi Co., Ltd.'s FDA import refusal history?
Sanmi Co., Ltd. (FEI: 3000140888) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2003 to 11/10/2003.
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. Sanmi Co., Ltd.'s FEI number is 3000140888.
What types of violations has Sanmi Co., Ltd. received?
Sanmi Co., Ltd. has been cited for 1 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 Sanmi Co., Ltd. come from?
All FDA import refusal data for Sanmi 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.