RUIE YUAN ENTERPRISE CO., LTD.
⚠️ Moderate Risk
FEI: 3009126636 • Tainan City • TAIWAN
FEI Number
3009126636
Location
Tainan City
Country
TAIWANAddress
No. 42, 1 F, Niaosong 2nd St.; Yongkang Dist., Tainan City, , Taiwan
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.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/1/2016 | 35AGT04GRASS JELLY (GELATIN PRODUCT) | Los Angeles District Office (LOS-DO) | |
| 11/23/2015 | 35AGT04GRASS JELLY (GELATIN PRODUCT) | Los Angeles District Office (LOS-DO) | |
| 11/20/2015 | 35AGT04GRASS JELLY (GELATIN PRODUCT) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is RUIE YUAN ENTERPRISE CO., LTD.'s FDA import refusal history?
RUIE YUAN ENTERPRISE CO., LTD. (FEI: 3009126636) has 3 FDA import refusal record(s) in our database, spanning from 11/20/2015 to 6/1/2016.
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. RUIE YUAN ENTERPRISE CO., LTD.'s FEI number is 3009126636.
What types of violations has RUIE YUAN ENTERPRISE CO., LTD. received?
RUIE YUAN ENTERPRISE CO., LTD. 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 RUIE YUAN ENTERPRISE CO., LTD. come from?
All FDA import refusal data for RUIE YUAN ENTERPRISE 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.